CFR 176 170

176.170 21 CFR Ch.
I (4105 Edition)
films or grease-resistant papers con- Provided, That the components of the

form with appropriate food additive food-contact surface consist entirely of
regulations. one or more of the substances identi-
(c) The labeling of the food additive fied in this paragraph: And provided fur-
shall contain adequate directions for ther, That if the paper or paperboard
its use to insure compliance with the when extracted under the conditions
requirements of paragraphs (a) and (b) prescribed in paragraph (c) of this sec-
of this section. tion exceeds the limitations on extrac-
tives contained in paragraph (c) of this
176.170 Components of paper and pa- section, information shall be available
perboard in contact with aqueous from manufacturing records from
and fatty foods. which it is possible to determine that
Substances identified in this section only substances identified in this para-
may be safely used as components of graph (a) are present in the food-con-
the uncoated or coated food-contact tact surface of such paper or paper-
surface of paper and paperboard in- board.
tended for use in producing, manufac- (1) Substances generally recognized
turing, packaging, processing, pre- as safe in food.
paring, treating, packing, transporting, (2) Substances generally recognized
or holding aqueous and fatty foods, as safe for their intended use in paper
subject to the provisions of this sec- and paperboard products used in food
tion. Components of paper and paper- packaging.
board in contact with dry food of the (3) Substances used in accordance
type identified under Type VIII of table with a prior sanction or approval.
1 in paragraph (c) of this section are (4) Substances that by regulation in
subject to the provisions of 176.180. parts 170 through 189 of this chapter
(a) Substances identified in para- may be safely used without extractives
graph (a) (1) through (5) of this section limitations as components of the
may be used as components of the food- uncoated or coated food-contact sur-
contact surface of paper and paper- face of paper and paperboard in contact
board. Paper and paperboard products with aqueous or fatty food, subject to
shall be exempted from compliance the provisions of such regulation.
with the extractives limitations pre- (5) Substances identified in this para-
scribed in paragraph (c) of this section: graph, as follows:
List of Substances Limitations
Acetyl peroxide ............................................................................ For use only as polymerization catalyst.

Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet-
taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper-
monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper-
percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of
has a minimum viscosity of 600 centipoises at 75 F, as de- 0.05 percent by weight of dry fibers in the finished paper and
termined by LVG-series Brookfield viscometer (or equivalent) paperboard.
using a No. 2 spindle at 30 r.p.m.
Acrylamide-b-methacrylyloxyethyltrimethylammonium methyl For use only as a retention aid and flocculant employed prior
sulfate copolymer resins containing not more than 10 molar to the sheet-forming operation in the manufacture of paper
percent of b-methacrylyloxyethyltrimethylammonium methyl and paperboard.
sulfate and containing less than 0.2% of residual acrylamide
monomer.
Acrylic acid, sodium salt copolymer with polyethyleneglycol allyl For use only in paper mill boilers.
ether (CAS Reg. No. 86830151).
Acrylic acid copolymer with 2-acrylamido-2-methylpropane-sul- For use only as a scale inhibitor prior to the sheet-forming op-
fonic acid (CAS Reg. No. 40623754) and/or its ammo- eration in the manufacture of paper and paperboard and
nium/alkali metal mixed salts. The copolymer is produced by used at a level not to exceed 1.0 kilogram (2.2 pounds) of
poly-merization of acrylic acid and 2-acrylamido-2- copolymer per 907 kilograms (1 ton) of dry paper and paper-
methylpropane-sulfonic acid in a weight ratio of 60/40, such board fibers.
that a 28 percent by weight aqueous solution of the polymer
has a viscosity of 75150 centipoises at 25 C as deter-
mined by LV-series Brookfield viscometer (or equivalent)
using a No. 2 spindle at 60 r.p.m.
196
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Food and Drug Administration, HHS 176.170
Acrylonitrile polymer, reaction product with ethylenediamine For use only as a size promoter and retention aid at a level not
sulfate having a nitrogen content of 22.525.0 percent (Kjel- to exceed 0.5 percent by weight of the dry paper and paper-
dahl dry basis) and containing no more than 0.075 percent board.
monomer as ethylenediamine. The finished resin in a 24 per-
cent by weight aqueous solution has a viscosity of 1,000
2,000 centipoises at 25 C as determined by LVT-series
Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or
by other equivalent method).
Acrylonitrile polymer with styrene, reaction product with ethyl- 1. For use only as a sizing material applied after the sheet-
enediamine acetate, having a nitrogen content of 7.48.3 forming operation in the manufacture of paper and paper-
percent (Kjeldahl dry basis) and containing no more than board in such amount that the paper and paperboard will
0.25 percent monomer as ethylenediamine. contain the additive at a level not in excess of 0.25 percent
by weight of the dry paper and paperboard.
2. For use only as a sizing material applied prior to the sheet-
forming operation in the manufacture of paper and paper-
board in such amount that the paper and paperboard will
contain the additive at a level not in excess of 1.0 percent by
weight of the dry paper and paperboard.
1-Alkenyl olefins, containing not less than 72 percent of C30 For use only under the following conditions:
and higher olefins. 1. In coatings for paper and paperboard with food of Types I,
II, IV-B, and VII-B described in table 1 of paragraph (c) of
this section under conditions of use E, F, and G described in
table 2 of paragraph (c) of this section.
2. In coatings for paper and paperboard with food of Type VIII
described in table I of paragraph (c) of this section under
conditions of use A through H described in table 2 of para-
graph (c) of this section.
(2-Alkenyl) succinic anhydrides mixture, in which the alkenyl For use only as a sizing agent employed prior to the sheet-
groups are derived from olefins which contain not less than forming operation in the manufacture of paper and paper-
95 percent of C15-C21 groups. board and limited to use at a level not to exceed 1 percent
by weight of the finished dry paper and paperboard fibers.
Alkyl(C12-C20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheet-forming
Reg. No. 27401065). operation in the manufacture of paper and paperboard.
tert-Alkyl(C8-C16)mercaptans ....................................................... For use only as polymerization-control agent.
Aluminum acetate.
2-Amino-2-methyl-1-propanol (CAS Reg. No. 124685) .......... For use as a dispersant for pigment suspension at a level not
to exceed 0.25 percent by weight of pigment. The suspen-
sion is used as a component of coatings for paper and pa-
perboard under conditions of use described in paragraph (c)
of this section, table 2, conditions of use E through G.
Ammonium bis(N-ethyl-2-perfluoroalkylsulfonamido ethyl) For use only as an oil and water repellant at a level not to ex-
phosphates, containing not more than 15% ammonium mono ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square
(N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, feet of treated paper or paperboard of a sheet basis weight
where the alkyl group is more than 95% C8 and the salts of 100 pounds or less per 3,000 square feet of paper or pa-
have a fluorine content of 50.2% to 52.8% as determined on perboard, and at a level not to exceed 0.5 pound (0.26
a solids basis. pound of fluorine) per 1,000 square feet of treated paper or
paperboard having a sheet basis weight greater than 100 lb.
per 3,000 square feet as determined by analysis for total flu-
orine in the treated paper or paperboard without correction
for any fluorine that might be present in the untreated paper
or paperboard, when such paper or paperboard is used as
follows:
1. In contact, under conditions of use C, D, E, F, G, or H de-
scribed in table 2 of paragraph (c) of this section, with non-
alcoholic food.
2. In contact with bakery products of Type VII, VIII, and IX de-
scribed in table I of paragraph (c) of this section under good
manufacturing practices of commercial and institutional bak-
ing.
Ammonium persulfate.
Ammonium thiosulfate.
Ammonium zirconium carbonate (CAS Reg. No. 32535845) For use only as an insolubilizer for binders used in coatings for
and its tartaric acid adduct. paper and paperboard, and limited to use at a level not to
exceed 2.5 percent by weight of coating solids.
Ammonium zirconium citrate (CAS Reg. No. 149564625), For use as insolubilizers with protein binders in coatings for
ammonium zirconium lactate-citrate (CAS Reg. No. 149564 paper and paperboard, at a level not to exceed 1.4 percent
647), ammonium zirconium lactate (CAS Reg. No. 149564 by weight of coating solids.
636).
197
176.170 21 CFR Ch. I (4105 Edition)
Anionic polyurethane, produced by reacting the preliminary For use only as a surface sizing agent at a level not to exceed
adduct formed from the reaction of glyceryl monostearate 0.1 percent by weight of dry paper and paperboard.
and 2,4-toluenediisocyanate with not more than 10 mole per-
cent N-methyldiethanolamine and not less than 90 mole per-
cent dimethylolpropionic acid. The final product is a 15 to 20
percent by weight aqueous solution, having a Brookfield vis-
cosity of 25 to 100 centipoises at 24 C (75 F).
9,10Anthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of
84651) which has a purity of not less than 98 percent. lignocellulosic material at levels not to exceed 0.1 percent by
weight of the raw lignocellulosic material.
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as modifiers in wax polymer blend coatings for
Reg. No. 88526470), produced by the catalytic polym- paper and paperboard at a level not to exceed 50 weight-
erization of aromatic substituted olefins from low boiling dis- percent of the coating solids under conditions of use E, F,
tillates of cracked petroleum stocks with a boiling point no and G identified in table 2 of paragraph (c) of this section.
greater than 220 C (428 F), and the subsequent catalytic
reduction of the resulting aromatic petroleum hydrocarbon
resin. The resin meets the following specifications: softening
point 85 C (185 F) minimum, as determined by ASTM
Method E 2867 (Reapproved 1982), Standard Test Meth-
od for Softening Point by Ring-and-Ball Apparatus, and ani-
line point 70 C (158 F) minimum, as determined by ASTM
Method D 61182, Standard Test Methods for Aniline Point
and Mixed Aniline Point of Petroleum Products and Hydro-
carbon Solvents, which are incorporated by reference in ac-
cordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American Society for Testing and
Materials, 1916 Race St., Philadelphia, PA 19103, or may be
examined at the National Archives and Records Administra-
tion (NARA). For information on the availability of this mate-
rial at NARA, call 2027416030, or go to: http://
www.archives.gov/federallregister/
codeloflfederallregulations/ibrllocations.html..
Azo-bisisobutyronitrile .................................................................. For use only as polymerization catalyst.
1,2-Benzisothiazolin-3-one (CAS Registry No. 2634335) ....... For use only as a preservative in paper coating compositions
and limited to use at a level not to exceed 0.01 mg/in2
(0.0016 mg/cm2) of the finished paper and paperboard.
Benzoyl peroxide ......................................................................... Do.
N,N-Bis(2-hydroxyethyl)alkyl (C12-C18)amide .............................. For use only as an adjuvant to control pulp absorbency and
pitch content in the manufacture of paper and paperboard
prior to the sheet forming operation.
Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine For use only under the following conditions:
resins having a 5.86.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op-
No. 68412271). eration in the manufacture of paper and paperboard in such
amount that the finished paper and paperboard will contain
the additive at a level not in excess of 1.6 percent by weight
of the finished dry paper and paperboard fibers.
2. The finished paper and paperboard will be used in contact
with nonalcoholic foods only.
3. As a water repellant employed after the sheet-forming oper-
ation in the manufacture of paper and paperboard in such
amount that the finished paper and paperboard will contain
the additive at a level not to exceed 1.6 percent by weight of
the finished dry paper and paperboard fibers. The finished
paper and paperboard will be used only in contact with food
of Types I, II, IV-B, VI, VII-B, and VIII described in table 1 of
paragraph (c) of this section.
2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52517) ........ For use only as an antimicrobial/preservative in fillers, pigment
slurries, starch sizing solutions, and latex coatings at levels
not to exceed 0.01 percent by weight of those components.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent in package coating inks at
salt (also known as butanedioic acid, sulfo-1,4-diisodecyl levels not to exceed 3 percent by weight of the coating ink.
ester, ammonium salt [CAS Reg. No. 144093889])..
tert-Butyl hydroperoxide .............................................................. For use only as polymerization catalyst.
tert-Butyl peroxide ....................................................................... Do.
Calcium isostearate ..................................................................... For use only with n-decyl alcohol as a stabilizing material for
aqueous calcium stearate dispersions intended for use as
components of coatings for paper and paperboard.
Carrageenan and salts of carrageenan as described in
172.620 and 172.626 of this chapter.
Castor oil, hydrogenated.
Castor oil, sulfated, ammonium, potassium, or sodium salt.
Cellulose, regenerated.
Chloracetamide ............................................................................ For use only as polymerization-control agent.
Cobaltous acetate ........................................................................ For use only as polymerization catalyst.
198
Cumene hydroperoxide ............................................................... Do.

Cyanoguanidine ........................................................................... For use only:
1. As a modifier for amino resins.
2. As a fluidizing agent in starch and protein coatings for paper
and paperboard.
n-Decyl alcohol ............................................................................ For use only with calcium isostearate as a stabilizing material
for aqueous calcium stearate dispersions intended for use as
components of coatings for paper and paperboard.
Dialdehyde guar gum .................................................................. For use only as a wet-strength agent employed prior to the
sheet-forming operation in the manufacture of paper and pa-
perboard and used at a level not to exceed 1% by weight of
the finished dry paper and paperboard fibers.
Dialdehyde locust bean gum ....................................................... Do.
Dialkyl(C16-C18)carbamoyl chloride (CAS Reg. No. 4131954 For use as a sizing agent at a level not to exceed 0.2 percent
4) manufactured by the reaction of secondary amines de- by weight of the dry fiber.
rived from fatty acids of animal or vegetable sources with
phosgene.
Diallyldimethyl ammonium chloride polymer with acrylamide For use only as a retention and/or drainage aid employed prior
and potassium acrylate, produced by copolymerizing either to the sheet-forming operations in the manufacture of paper
(1) diallyldimethyl ammonium chloride and acrylamide in a and paperboard and limited to use at a level not to exceed
weight ratio of 50/50, with 4.4 percent of the acrylamide sub- 0.05 percent by weight of the finished paper and paper-
sequently hydrolyzed to potassium acrylate or (2) polym- board.
erized diallyldimethyl ammonium chloride, acrylamide and
potassium acrylate (as acrylic acid) in a weight ratio of 50/
47.8/2.2, respectively, so that the finished resin in a 1 per-
cent by weight aqueous solution (active polymer) has a vis-
cosity of more than 22 centipoises at 22 C (72 F) as deter-
mined by LVF series, Brookfield Viscometer using No. 1
spindle at 60 RPM (or by other equivalent method) (CAS
Reg. No. 25136758).
Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior
No. 26590056). The copolymer is produced by copolym- to the sheet-forming operation in the manufacture of paper
erizing diallyldimethylammonium chloride with acrylamide in and paperboard and limited to use at a level not to exceed
a weight ratio of 5050 so that the finished resin in a 1 per- 0.05 percent by weight of the finished paper and paper-
cent by weight aqueous solution (active polymer) has a vis- board.
cosity of more than 22 centipoises at 22 C (71.6 F), as de-
termined by LVF-series Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or by other equivalent method).
Diallyldiethylammonium chloride polymer with acrylamide, and
diallyldimethylammonium chloride, produced by copolym-
erizing acrylamide, diallyldiethylammonium chloride, and
diallyldimethylammonium chloride, respectively, in the fol-
lowing weight ratios and having viscosities determined at 22
C, by LVF-series Brookfield viscometer using a No. 1 spin-
dle at 60 r.p.m. (or by other equivalent method), as follows:.
1. Weight ratio: 502.547.5. The finished resin in a 1 per- For use only as a retention aid employed prior to the sheet-
cent by weight aqueous solution has a minimum vis- forming operation in the manufacture of paper and paper-
cosity of 22 centipoises. board and limited to use at a level not to exceed 0.05 per-
cent by weight of the finished paper and paperboard.
2. Weight ratio: 252.572.5. The finished resin in a 0.20 For use only as a drainage and/or retention aid employed prior
percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper
cosity of 20 centipoises. and paperboard and limited to use at a level not to exceed
0.075 percent by weight of the finished paper and paper-
board.
3. Weight ratio: 802.517.5. The finished resin in a 0.30 For use only as a drainage and/or retention aid employed prior
percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper
cosity of 50 centipoises. and paperboard and limited to use at a level not to exceed
0.075 percent by weight of the finished paper and paper-
board.
199
176.170 21 CFR Ch. I (4105 Edition)
Diallyldiethylammonium chloride polymer with acrylamide, po- For use only as a retention aid employed prior to the sheet-
tassium acrylate, and diallyldimethylammonium chloride. The forming operation in the manufacture of paper and paper-
polymer is produced by copolymerizing either: (1) acryl- board and limited to use at a level not to exceed 0.05 per-
amide, diallyldiethylammonium chloride, and cent by weight of the finished paper and paperboard.
diallyldimethylammonium chloride in a weight ratio of 50
2.547.5, respectively, with 4.4 percent of the acrylamide
subsequently hydrolyzed to potassium acrylate, or (2) acryl-
amide, potassium acrylate (as acrylic acid),
diallyldiethylammonium chloride, and
diallyldimethylammonium chloride in a weight ratio of 47.8
2.22.547.5, so that the finished resin in a 1 percent by
weight aqueous solution has a minimum viscosity of 22 cen-
tipoises at 22 C, as determined by LVF-series Brookfield
viscometer using a No. 1 spindle at 60 r.p.m. (or by other
equivalent method).
Diallyldimethylammonium chloride polymer with acrylamide, re- For use only as a dry and wet strength agent employed prior
action product with glyoxal, produced by copolymerizing not to the sheet-forming operation in the manufacture of paper
less than 90 weight percent of acrylamide and not more than and paperboard in such an amount that the finished paper
10 weight percent of diallyldimethylammonium chloride, and paperboard will contain the additive at a level not in ex-
which is then cross-linked with not more than 30 weight per- cess of 2 percent by weight of the dry fibers in the finished
cent of glyoxal, such that a 10 percent aqueous solution has paper and paperboard.
a minimum viscosity of 25 centipoises at 25 C as deter-
mined by Brookfield viscometer Model RVF, using a No. 1
spindle at 100 r.p.m.
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222012). For use as a preservative at a level not to exceed 100 parts
per million in coating formulations and in component slurries
and emulsions, used in the production of paper and paper-
board and coatings for paper and paperboard.
2,5-Di-tert-butyl hydroquinone ..................................................... For use only as an antioxidant for fatty based coating adju-
vants provided it is used at a level not to exceed 0.005% by
weight of coating solids.
Diethanolamine ............................................................................ For use only:
1. As an adjuvant to control pulp absorbency and pitch content
in the manufacture of paper and paperboard prior to the
sheet-forming operation.
2.In paper mill boilers.
Diethanolamine salts of mono- and bis (1H,1H,2H,2H-perfluo- For use only as an oil and water repellant at a level not to ex-
roalkyl) phosphates where the alkyl group is even-numbered ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square
in the range C8-C18 and the salts have a fluorine content of feet of treated paper or paperboard, as determined by anal-
52.4% to 54.4% as determined on a solids basis. ysis for total fluorine in the treated paper or paperboard with-
out correction for any fluorine which might be present in the
untreated paper or paperboard, when such paper or paper-
board is used in contact with nonalcoholic foods under the
conditions of use described in paragraph (c) of this section,
table 2, conditions of use (B) through (H).
Diethyl(2-hydroxyethyl) methylammonium methyl sulfate, acry- For use only as a retention aid and drainage aid employed
late, polymer with acrylamide, chemical abstract service reg- prior to the sheet-forming operation in the manufacture of
istry No. [26796758] having 9095 mole pct. acrylamide, a paper and paperboard at a level not to exceed 0.15 pct. by
nitrogen content of not more than 19.7 pct. (Kjeldahl, dry weight of finished dry paper and paperboard fibers.
basis), and a residual acrylamide monomer content of not
more than 0.1 pct. The finished polymer in a 1 pct. by weight
aqueous solution has a minimum viscosity of 900 centipoises
at 25 C as determined by LVT-series Brookfield viscometer
using a No. 2 spindle at 12 r.p.m. (or by equivalent method).
Diethylenetriamine ....................................................................... For use only as a modifier for amino resins.
N,N-Diisopropanolamide of tallow fatty acids ............................. For use only as an adjuvant to control pulp absorbency and
prior to the sheet-forming operation.
Dimethylamine-epichlorohydrin copolymer in which not more For use only:
than 5 mole-percent of dimethylamine may be replaced by 1. As a retention aid employed before the sheet-forming oper-
an equimolar amount of ethylenediamine and in which the ation in the manufacture of paper and paperboard and lim-
ratio of total amine to epichlorohydrin does not exceed 1:1. ited to use at a level not to exceed 1 percent by weight of
The nitrogen content of the copolymer shall be 9.4 to 10.8 the finished paper and paperboard.
weight percent on a dry basis and a 10 percent by weight 2. At the size press at a level not to exceed 0.017 percent by
aqueous solution of the final product has a minimum vis- weight of the finished paper and paperboard.
cosity of 5.0 centipoises at 25 C, as determined by LVT-se-
ries Brookfield viscometer using a No. 1 spindle at 60 r.p.m.
(or by other equivalent method).
N-[(Dimethylamino)methyl]-acrylamide polymer with acrylamide For use only as a dry-strength agent employed prior to the
and styrene having a nitrogen content of not more than 16.9 sheet-forming operation in the manufacture of paper and pa-
percent and a residual acrylamide monomer content of not perboard and used at a level not to exceed 1 percent by
more than 0.2 percent on a dry basis. weight of finished dry paper or paperboard fibers.
N,N-Dioleoylethylenediamine.
200
Diphenylamine ............................................................................. For use only as an antioxidant for fatty based coating adju-
vants provided it is used at a level not to exceed 0.005% by
Dipropylene glycol.
Disodium salt of 1,4-dihydro-9,10-dihydroxyanthracene (CAS For use only as a catalyst in the alkaline pulping of
Reg. No. 73347805). lignocellulosic materials at levels not to exceed 0.1 percent
by weight of the raw lignocellulosic materials.
N,N-Distearoylethylenediamine.
n-Dodecylguanidine acetate ........................................................ For use only as an antimicrobial agent in paper and paper-
board under the following conditions:
1. For contact only with nonalcoholic food having a pH above 5

and provided it is used at a level not to exceed 0.4 percent
by weight of the paper and paperboard.
2. For use in the outer ply of multiwall paper bags for contact
with dry food of Type VIII described in table I of paragraph
(c) of this section and provided it is used at a level of 0.8
percent by weight of the paper.
n-Dodecylguanidine hydrochloride .............................................. For use only as an antimicrobial agent in paper and paper-
board under the following conditions:
1. For contact only with nonalcoholic food having a pH above 5
and provided it is used at a level not to exceed 0.4 percent
by weight of the paper and paperboard.
2. For use in the outer ply of multiwall paper bags for contact
with dry food of Type VIII described in table I of paragraph
(c) of this section and provided it is used at a level of 0.8
percent by weight of the paper.
Fatty acids derived from animal and vegetable fats and oils
and salts of such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Ferric chloride.
Ferrous ammonium sulfate.
Fish oil, hydrogenated.
Fish oil, hydrogenated, potassium salt.
Furcelleran and salts of furcelleran as described in 172.655
and 172.660 of this chapter.
Glutaraldehyde (CAS Reg. No. 111308) ................................. For use only as an antimicrobial agent in pigment and filler
slurries used in the manufacture of paper and paperboard at
levels not to exceed 300 parts per million by weight of the
slurry solids.
Glyceryl lactostearate.
Glyceryl mono-1,2-hydroxystearate.
Glyceryl monoricinoleate.
Guar gum modified by treatment with b-diethylamino- ethyl For use only as a retention aid and/or drainage aid employed
chloride hydrochloride. prior to the sheet-forming operation in the manufacture of
paper and paperboard.
Guar gum modified by treatment with not more than 25 weight For use only as a retention aid and/or internal size employed
percent of 2,3-epoxypropyltri-methylammonium chloride such prior to the sheet-forming operation in the manufacture of
that the finished product has a maximum chlorine content of paper and paperboard, and limited to use at a level: (1) Not
4.5 percent, a maximum nitrogen content of 3.0 percent, and to exceed 0.15 percent by weight of the finished dry paper
a minimum viscosity in 1-percent-by-weight aqueous solution and paperboard fibers intended for use in contact with all
of 1,000 centipoises at 77 F, as determined by RV-series types of foods, except (2) not to exceed 0.30 pct. by weight
Brookfield viscometer (or equivalent) using a No. 3 spindle at of the finished dried paper and paperboard fibers for use
20 r.p.m. with nonalcoholic and nonfatty food of types identified under
Types I, II, IV-B, VI-B, VII-B, and VIII of table I in par. (c) of
this section.
N, N, N, N, N, N-Hexakis (methoxymethyl)-1,3,5-triazine-2,4,6- For use only as a water-repellent applied to the surface of
triamine polymer with stearyl alcohol, a-octadecenyl-omega- paper and paperboard at levels not to exceed 1 percent by
hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20+) alcohols weight of the finished dry paperboard fibers. The finished
(CAS Reg. No. 130328244). paper and paperboard will be used in contact with aqueous
foods under conditions of use B through G as described in
table 2 of paragraph (c) of this section.
Hexamethylenetetramine ............................................................. For use only as polymerization cross-linking agent for protein,
including casein.
Hydroquinone and the monomethyl or monoethyl ethers of hy- For use only as an inhibitor for monomers.
droquinone.
201
176.170 21 CFR Ch. I (4105 Edition)
Hydroxymethyl-5,5-dimethylhydantoin (CAS Reg. No. 27636 For use only as a preservative in clay-type fillers at a level not
824), mixture with 1,3-bis(hydroxymethyl)-5,5- to exceed a combined total of 1,200 milligrams/kilograms
dimethylhydantoin (CAS Reg. No. 6440580). hydroxymethyl-5,5-dimethylhydantoin and 1,3-
bis(hydroxymethyl)-5,5-dimethylhydantoin in the filler.
Hydroxypropyl guar gum having a minimum viscosity of 5,000 For use only as a dry strength and formation aid agent em-
centipoises at 25 C., as determined by RV-series Brookfield ployed prior to the sheet-forming operation in the manufac-
viscometer using a No. 4 spindle at 20 r.p.m. (or other suit- ture of paper and paperboard and used at a level not to ex-
able method) and using a test sample prepared by dissolving ceed 1.5 percent by weight of finished dry paper or paper-
5 grams of moisture-free hydroxypropyl guar gum in 495 mil- board fibers.
liliters of a 70 percent by weight aqueous propylene glycol
solution.
12-Hydroxystearic acid-polyethylene glycol block copolymers For use only as a surfactant for dispersions of polyacrylamide
(CAS Reg. No. 70142346) produced by the reaction of retention and drainage aids employed prior to the sheet
polyethylene glycol (minimum molecular weight 200) with 12- forming operation in the manufacture of paper and paper-
hydroxystearic acid. board.
Imidazolium compounds, 2(C17 and C17-unsaturated alkyl)-1 For use only at a level not to exceed 0.5 percent by weight of
[2(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard.
methyl, methyl sulfates (CAS Reg. No. 72749554)..
Isopropyl m- and p-cresols (thymol derived) ............................... For use only as an antioxidant for fatty based coating adju-
vants provided it is used as a level not to exceed 0.005% by
Isopropyl peroxydicarbonate ....................................................... For use only as polymerization catalyst.
Japan wax.
Lanolin.
Lauryl peroxide ............................................................................ For use only as polymerization catalyst.
Lauryl sulfate salts:
Ammonium.
Magnesium.
Potassium.
Sodium.
Lecithin, hydroxylated.
Lignin sulfonate and its calcium, potassium, and sodium salts.
Maleic anhydride, polymer with ethyl acrylate and vinyl acetate, For use only as a deposit control additive prior to the sheet
hydrolyzed (CAS Reg. No. 113221695) and/or its ammo- forming operation to prevent scale buildup in the manufac-
nium, potassium, and sodium salts. ture of paper and paperboard in contact with food, at a level
not to exceed 0.075 percent (as the acid) by weight of the
dry paper and paperboard.
Methacrylic acid-acrylic acid copolymer (CAS Reg. No. 25751 For use only as a boiler water additive at a level not to exceed
217). 50 parts per million in the boiler water.
N-methyldiallylamine hydrochloride polymer with For use only as a retention aid, flocculating agent, and wet-
epichlorohydrin having a nitrogen content of 4.8 to 5.9 per- strength agent employed in the manufacture of paper and
cent (Kjeldahl dry basis) such that a 20 percent by weight paperboard prior to the sheet-forming operation and limited
aqueous solution has a minimum viscosity of 30 centipoises to use at a level not to exceed 1.5 percent by weight of the
and maximum viscosity of 100 centipoises at 25 C, as de- dry paper and paperboard.
termined by LVF Model Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or equivalent method).
Methyl naphthalene sulfonic acid-formaldehyde condensate, For use only as an adjuvant to control pulp absorbency and
sodium salt. pitch content in the manufacture of paper and paperboard
N-methyl-N-(tall oil acyl) taurine, sodium salt (CAS Reg. No. For use only to control scale formation in the manufacture of
61791411). paper and paperboard prior to the sheetforming operation at
a level not to exceed 0.015 percent by weight of the dry
paper and paperboard.
Mineral oil, white.
Mono-, di-, tri-(1-methyl-1-phenylethyl)-phenol, ethoxylated, For use only as an emulsifier for rosin based sizing at a level
sulfated, ammonium salt with an average of 12 to 16 moles not to exceed 0.03 percent by weight of the finished dry
of ethylene oxide (CAS Reg. No. 68130712). paper and paperboard.
Monoglyceride citrate.
Monoisopropanolamine (CAS Reg. No. 78966) ...................... For use as a dispersant for titanium dioxide suspensions at a
level not to exceed 0.68 percent by weight of titanium diox-
ide. The finished paper and paperboard will be used in con-
tact with all food types under conditions of use E through G
described in table 2 of paragraph (c) of this section.
Mustardseed oil, sulfated, ammonium, potassium, or sodium
salt.
Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only as an adjuvant to control pulp absorbency and
salt. pitch content in the manufacture of paper and paperboard
Nitrocellulose, 10.912.2% nitrogen.
Oleic acid, sulfated, ammonium, potassium, or sodium salt.
N-Oleoyl-N-stearoylethylenediamine.
Oxystearin.
Paraformaldehyde ....................................................................... For use only as setting agent for protein.
202
Pentanoic acid, 4,4bis [(gamma-omega-perfluoro-C820- For use only as an oil and water repellent and used at a level
alkyl)thio] derivatives, compounds with diethanolamine (CAS not to exceed 8 pounds per ton of the finished paper or pa-
Reg. No. 71608-61-2). perboard when such paper or paperboard is used in contact
with nonalcoholic foods under conditions of use E through H
described in table 2 of paragraph (c) of this section.
Perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265811) For use only as an oil and water repellent at a level not to ex-
containing 35 to 40 weight percent fluorine, produced by the ceed 0.5 percent by weight of the finished paper and paper-
copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2- board in contact with nonalcoholic foods under conditions of
methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2- use C, D, E, F, G, or H described in table 2 of paragraph (c)
methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl of this section.
ester; and 2-propenoic acid, 2[[(heptadecafluoro-
octyl)sulfonyl] methyl amino]ethyl ester.
Perfluoroalkyl substituted phosphate ester acids, ammonium For use only as an oil and water repellant at a level not to ex-
salts formed by the reaction of 2,2-bis[ (g,w-perfluoroC4-20 ceed 0.44 percent perfluoroalkyl actives by weight of the fin-
alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ished paper and paperboard in contact with non-alcoholic
ammonium hydroxide. foods under condition of use H as described in table 2 of
paragraph (c) of this section; and in contact with food of
types III, IV-A, V, VII-A, and IX described in table 1 of para-
graph (c) of this section under conditions of use C through G
as described in table 2 of paragraph (c) of this section.
Petrolatum ................................................................................... Complying with 178.3700 of this chapter.
Petroleum asphalt, steam and vacuum refined to meet the fol- For use only as a component of internal sizing of paper and
lowing specifications: Softening point 88 C to 93 C, as de- paperboard intended for use in contact only with raw fruits,
termined by ASTM method D3676, Standard Test Method raw vegetables, and dry food of the type identified under
for Softening Point of Bitumen (Ring-and-Ball Apparatus); Type VIII of table 1 in paragraph (c) of this section, and pro-
penetration at 25 C not to exceed 0.3 mm, as determined by vided that the asphalt is used at a level not to exceed 5% by
ASTM method D573 (Reapproved 1978), Standard Test weight of the finished dry paper and paperboard fibers.
Method for Penetration of Bituminous Materials, which are
incorporated by reference (Copies may be obtained from the
American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the National
Archives and Records Administration (NARA). For informa-
tion on the availability of this material at NARA, call 202
7416030, or go to: http://www.archives.gov/
federallregister/codeloflfederallregulations/
ibrllocations.html.); and maximum weight loss not to ex-
ceed 3% when distilled to 371 C, nor to exceed an addi-
tional 1.1% when further distilled between 371 C and ther-
mal decomposition.
Petroleum wax, synthetic ............................................................ Complying with 178.3720 of this chapter.
Phenothiazine .............................................................................. For use only as antioxidant in dry rosin size.
Phenyl acid phosphate ................................................................ For use only as polymerization catalyst in melamine-formalde-
hyde modified alkyd coatings and limited to use at a level
not to exceed 2% by weight of the coating solids.
Phenyl-b-naphthylamine .............................................................. For use only as antioxidant in dry rosin size and limited to use
at a level not to exceed 0.4% by weight of the dry rosin size.
Phosphoric acid esters and polyesters (and their sodium salts) For use as an adjuvant prior to the sheet forming operation to
of triethanolamine formed by the reaction of triethanolamine control pitch and scale formation in the manufacture of paper
with polyphosphoric acid to produce a mixture of esters hav- and paperboard intended for use in contact with food only of
ing an average nitrogen content of 1.5 percent and an aver- the types identified in paragraph (c) of this section, table 1,
age phosphorus content of 32 percent (as PO4). under Types I, IV, V, VII, VIII, and IX, and used at a level
not to exceed 0.075 percent by weight of dry paper or pa-
perboard fibers.
Poly[acrylamide-acrylic acid-N-(dimethyl-aminomethyl)acryl- For use only as a drainage aid and retention aid employed
amide], produced by reacting 2.40 to 3.12 parts by weight of prior to the sheet-forming operation in the manufacture of
polyacrylamide with 1.55 parts dimethylamine and 1 part paper and paperboard for use in contact with fatty foods
formaldehyde, and containing no more than 0.2 percent under conditions of use described in paragraph (c) of this
monomer as acrylamide. section, table 2, conditions of use E, F, and G.
Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate) For use only as a retention and drainage aid employed prior to
produced when one mole of hydroxypropyl acrylate and the sheet-forming operation in the manufacture of paper and
three moles of acrylic acid are reacted with three moles of paperboard at a level not to exceed 0.2 percent by weight of
ethylenimine and three moles of nitric acid, such that a 35 dry paper or paperboard fiber.
percent by weight aqueous solution has a minimum viscosity
of 150 centipoises at 72 F., as determined by RVF-series
Brookfield viscometer (or equivalent) using a No. 2 spindle at
20 r.p.m.
Polyacrolein (1 part) -sodium bisulfite (0.7 part) adduct, con- For use only as an agent in modifying starches and starch
taining excess bisulfite (ratio of excess bisulfite to adduct not gums used in the production of paper and paperboard and
to exceed 1.5 to 1). limited to use at a level not to exceed 0.09 mg/in2 of the fin-
ished paper and paperboard.
203
176.170 21 CFR Ch. I (4105 Edition)
Poly[acrylamide-acrylic acid-N-(dimethylaminomethyl) acryl- For use only as a drainage aid, retention aid, or dry-strength
amide] (C.A. Registry No. 53800412), produced by react- agent employed prior to the sheet-forming operation in the
ing 9.616.4 parts by weight of polyacrylamide with 1.6 parts manufacture of paper and paperboard at a level not to ex-
dimethylamine and 1 part formaldehyde, and containing no ceed 0.25 percent by weight of finished dry paper and pa-
more than 0.2% monomer as acrylamide, such that a 20% perboard fibers, when such paper or paperboard is used in
aqueous solution has a minimum viscosity of 4,000 cP at 25 contact with fatty foods under conditions of use described in
C., as determined by Brookfield viscometer model RVT, paragraph (c) of this section, table 2, conditions of use E, F,
using a No. 5 spindle at 20 r/min (or equivalent method). and G.
Polyamide-epichlorohydrin modified resin produced by reacting For use only as a retention aid and flocculant employed prior
adipic acid with diethylene triamine to produce a basic poly- to the sheet-forming operation in the manufacture of paper
amide which is modified by reaction with formic acid and and paperboard and used at a level not to exceed 0.2 per-
formaldehyde and further reacted with epichlorohydrin in the cent dry resin by weight of finished dry paper or paperboard
presence of ammonium hydroxide to form a water-soluble fibers.
cationic resin having a nitrogen content of 1316 percent
(Kjeldahl, dry basis) such that a 35 percent by weight aque-
ous solution has a minimum viscosity of 75 centipoises at 25
C, as determined by Brookfield viscometer using a No. 1
spindle at 12 r.p.m.
Polyamide-epichlorohydrin water-soluble thermosetting resins For use only under the following conditions:
[CAS Reg. No. 68583799] prepared by reacting adipic 1. As a retention aid employed prior to the sheet-forming oper-
acid with diethylenetriamine to form a basic polyamide and ation in the manufacture of paper and paperboard and lim-
further reacting the polyamide with an epichlorohydrin and ited to use at a level not to exceed 0.12 percent by weight of
dimethylamine mixture such that the finished resins have a dry paper or paperboard.
nitrogen content of 17.0 to 18.0 percent of a dry basis, and 2. The finished paper or paperboard will be used in contact
that a 30-percent-by-weight aqueous solution has a minimum with food only of the types identified in paragraph (c) of this
viscosity of 350 centipoises at 20 C, as determined by a section, table 1, under types I and IV-B and under conditions
Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or of use described in paragraph (c) of this section, table 2,
equivalent method). conditions of use F and G.
Polyamide-epichlorohydrin water-soluble thermosetting resin For use only as a wet strength agent and/or retention aid em-
(CAS Reg. No. 96387483) prepared by reacting N-methyl- ployed prior to the sheet-forming operation in the manufac-
bis(3-aminopropyl) amine with oxalic acid and urea to form a ture of paper and paperboard and used at a level not to ex-
basic polyamide and further reacting the polyamide with ceed 1.5 percent by weight of dry paper and paperboard fi-
epichlorohydrin. bers.
Polyamide-epichlorohydrin water-soluble thermosetting resins For use only in the manufacture of paper and paperboard
prepared by reacting adipic acid, isophthalic acid, itaconic under conditions such that the resins do not exceed 1.5 per-
acid or dimethyl glutarate with diethylenetriamine to form a cent by weight of the paper or paperboard.
basic polyamide and further reacting the polyamide with one
of the following:
Epichlorohydrin.
Epichlorohydrin and ammonia mixture.
Epichlorohydrin and sodium hydrosulfite mixture.
Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared For use only as a retention aid employed prior to the sheet-
by reacting hexanedioic acid, N-(2-aminoethyl)-1,2- forming operation in the manufacture of paper and paper-
ethanediamine, (chloromethyl)oxirane, ethyleneimine board at a level not to exceed 0.12 percent resin by weight
(aziridine), and polyethylene glycol, partly neutralized with of the finished dry paper or paperboard.
sulfuric acid (CAS Reg. No. 167678457).
Polyamidol-epichlorohydrin modified resin produced by reacting For use only as a wet strength agent employed prior to the
glutaric acid dimethyl ester with diethylene-triamine to sheet-forming operation in the manufacture of paper and pa-
produce a basic polyamide which is modified by reaction perboard, and used at a level not to exceed 2.5 percent by
with formaldehyde and further reacted with epicholorohydrin weight of dry paper and paperboard fibers when such paper
to form a water soluble cationic resin having a nitrogen con- or paperboard is used in contact with food under conditions
tent of 10.911.9 percent and a chlorine content of 13.8 of use E through G described in table 2 of paragraph (c) of
14.8 percent, on a dry basis, and a minimum viscosity, in this section.
12.5 percent by weight aqueous solution, of 10 centipoises
at 25 C, as determined by a Brookfield Model LVF viscom-
eter using a No. 1 spindle at 60 r.p.m. (or equivalent meth-
od).
Polyamine-epichlorohydrin resin produced by the reaction of For use only as a flocculant, drainage aid, formation aid, reten-
epichlorohydrin with monomethylamine to form a prepolymer tion aid, or strength additive employed prior to the sheet-
and further reaction of this prepolymer with N,N,N,N- forming operation in the manufacture of paper and paper-
tetramethylethylenediamine such that the finished resin hav- board, and used at a level not to exceed 0.12 percent by
ing a nitrogen content of 11.6 to 14.8 percent and a chlorine weight of dry paper and paperboard fibers.
content of 20.8 to 26.4 percent and a minimum viscosity, in
25 percent by weight aqueous solution, of 500 centipoises at
25 C, as determined by LV-series Brookfield viscometer
using a No. 2 spindle at 12 r.p.m. (or by other equivalent
method).
204
Polyamine-epichlorohydrin resin produced by the reaction of For use only as a clarifier in the treatment of influent water to
N,N-dimethyl-1,3-propanediamine with epichlorohydrin and be used in the manufacture of paper and paperboard, and
further reacted with sulfuric acid, Chemical Abstracts Service used at a level not to exceed 20 parts per million of the influ-
Registry Number [27029410], such that the finished resin ent water.
has a maximum nitrogen content of 14.4 percent (dry basis)
and a minimum viscosity in 30 percent by weight aqueous
solution (pH 46) of 50 centipoises at 25 C, as determined
by Brookfield LVT model viscometer, using a No. 1 spindle
at 12 r.p.m. (or equivalent method).
Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wetstrength agent and/or retention aid em-
produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac-
comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex-
diamines and/or their self-condensation products, and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi-
prepolymers produced by reacting 1,2-dichloroethane with bers.
the polyamines in (i). The finished resin has a nitrogen con-
tent of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0
percent on a dry basis, and a minimum viscosity, in a 25
percent by weight aqueous solution, of 50 centipoises at 20
C (68 F), as determined by Brookfield HAT model viscom-
eter using a No. 1H spindle at 50 r.p.m. (or equivlent meth-
od).
Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em-
produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac-
comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex-
diamines and/or their seIf-condensation products and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi-
hexamethylenediamine, and/or (iii) bis(hexamethylene) tri- bers.
amine and higher homologues, and/or (iv) prepolymers pro-
duced by reacting 1,2-dichloroethane with the polyamines in
(i) and/or (ii) and/or (iii). The finished resin has a nitrogen
content of 5.0 to 9.0 percent, a chlorine content of 18.0 to
35.0 percent on a dry basis, and a minimum viscosity, in a
25 percent by weight aqueous solution, of 50 centipoises at
20 C (68 F), as determined by Brookfield HAT model vis-
cometer using a No. 1H spindle at 50 r.p.m. (or equivalent
method).
Polyamine-epichlorohydrin water soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em-
prepared by reacting hexamethylenediamine with 1,2-di- ployed prior to the sheet-forming operation in the manufac-
chloroethane to form a prepolymer and further reacting this ture of paper and paperboard, and used at a level not to ex-
prepolymer with epichlorohydrin. This resin is then reacted ceed 1 percent by weight of dry paper and paperboard fi-
with nitrilotris (methylene-phosphonic acid), pentasodium bers.
salt, such that the finished resin has a nitrogen content of
5.05.3 percent; a chlorine content of 29.731.3 percent;
and a phosphorus content of 2.02.2 percent, on a dry
basis, and a minimum viscosity, in 25 percent by weight
aqueous solution, of 50 centipoises at 25 C., as determined
on a Brookfield HAT model viscometer using a No. 1H spin-
dle at 50 r.p.m. (or equivalent method).
Polyamine resin produced by the reaction of 1,2-dichloroethane For use only as a retention aid and/or flocculent employed
with bis(hexamethylene)triamine and higher homologues prior to the sheet-forming operation in the manufacture of
such that the finished resin has a nitrogen content of 13.0 paper and paperboard and used at a level not to exceed 0.1
15.0 percent on a dry basis, and a minimum viscosity in 25- percent by weight of dry paper or paperboard fibers.
percent-by-weight aqueous solution of 75 centipoises at 25
C., as determined by Brookfield HAT model viscometer
using a No. 1 spindle at 50 r.p.m. (or equivalent method).
Polyaminoamide-epichlorohydrin modified resin produced by For use only as a wet-strength agent and/or retention aid em-
reacting adipic acid with diethylenetriamine to produce a pol- ployed prior to the sheet-forming operation in the manufac-
yamide which is modified by reaction with ture of paper and paperboard, and used at a level not to ex-
diethylaminopropylamine and further reacted with dichlor- ceed 0.5 percent by weight of the finished dry paper and pa-
oethyl ether to form a polyamide intermediate. This poly- perboard.
amide intermediate is then reacted with epichlorohydrin such
that the finished resins have a nitrogen content of 10.912.4
percent (Kjeldahl, dry basis) and a minimum viscosity in 40
percent-by-weight aqueous solution of 250 centipoises at 22
C, as determined by a Brookfield Model LVT viscometer
using a No. 2 spindle at 30 r.p.m. (or equivalent method).
Polybutene, hydrogenated; complying with the identity pre- For use only as provided in 175.300, 178.3740 and
scribed under 178.3740(b) of this chapter. 178.3860 of this chapter.
205
176.170 21 CFR Ch. I (4105 Edition)
Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062 For use only:

793) produced by the polymerization of 1. As a pigment dispersant and/or retention aid prior to the
(diallyldimethylammonium chloride) so that the finished resin sheet-forming operation in the manufacture of paper and pa-
has a nitrogen content of 8.660.4 percent on a dry weight perboard, and used at a level not to exceed 10 pounds of
basis and a minimum viscosity in a 40 percent by weight active polymer per ton of finished paper and paperboard.
aqueous solution of 1,000 centipoises at 25 C (77 F), de- 2. As a pigment dispersant in coatings at a level not to exceed
termined by LVF Model Brookfield Viscometer using a No. 3 3.5 pounds of active polymer per ton of finished paper and
spindle at 30 r.p.m. (or equivalent method). The level of re- paperboard.
sidual monomer is not to exceed 1 percent by weight of the
polymer (dry basis).
Poly (diallyldimethylammonium chloride) (CAS Reg. No. For use only as a flocculant employed prior to the sheet-form-
26062793) produced by the polymerization of ing operation in the manufacture of paper and paperboard,
diallyldimethylammonium chloride so that the finished resin and used at a level not to exceed 10 mg/L (10 parts per mil-
has a nitrogen content of 8.660.4 percent on a dry basis lion) of influent water.
and a minimum viscosity in a 15 weight-percent aqueous so-
lution of 10 centipoises at 25 C (77 F), as determined by
LVF Model Brookfield viscometer using a No. 1 spindle at 60
r/min (or equivalent method). The level of residual monomer
is not to exceed 1 weight-percent of the polymer (dry basis).
Poly(1,2-dimethyl-5-vinylpyridinium methyl sulfate) having a ni- For use only as an adjuvant employed in the manufacture of
trogen content of 5.7 to 7.3 percent and a sulfur content of paper and paperboard prior to the sheet-forming operation.
11.7 to 13.3 percent by weight on a dry basis and having a
minimum viscosity in 30-percent-by-weight aqueous solution
of 2,000 centipoises at 25 C., as determined by LV-series
Brookfield viscometer (or equivalent) using a No. 4 spindle at
60 r.p.m.
Polyester resin produced by reacting dimethylolpropionic acid For use only as a surface-sizing compound applied after the
(CAS Registry No. 4767037) as a comonomer, at no more sheet-forming operation in the manufacture of paper and pa-
than 30 percent by weight of total polymer solids in reaction perboard and limited to use at levels not to exceed 0.1 per-
with 2,2-dimethyl-1,3-propanediol, phthalic anhydride and cent by weight of finished dry paper or paperboard.
isophthalic acid, such that the polyester resin has a viscosity
of 200600 centipoises at 80 F as determined by a Brook-
field RVT viscometer using a number 3 spindle at 50 rpm (or
equivalent method).
Polyethylene, oxidized; complying with the identity prescribed For use only as component of coatings that contact food only
in 177.1620(a) of this chapter. of the type identified under Type VII-B of table 1 in para-
graph (c) of this section, and limited to use at a level not to
exceed 50 percent by weight of the coating solids.
Polyethyleneamine mixture produced when 1 mole of ethylene For use only as a retention aid employed prior to the sheet-
dichloride, 1.05 moles of ammonia, and 2 moles of sodium forming operation in the manufacture of paper and paper-
hydroxide are made to react so that a 10 percent aqueous board.
solution has a minimum viscosity of 40 centipoises at 77 F,
as determined by Brookfield viscometer using a No. 1 spin-
dle at 60 r.p.m.
Polyethylene glycol (200) dilaurate ............................................. For use only as an adjuvant employed in the manufacture of
paper and paperboard prior to the sheet-forming operation.
Polyethylene glycol (400) dioleate.
Polyethylene glycol (400) esters of coconut oil fatty acids.
Polyethylene glycol (600) esters of tall oil fatty acids.
Polyethylene glycol (400) monolaurate.
Polyethylene glycol (600) monolaurate.
Polyethylene glycol (400) monooleate.
Polyethylene glycol (600) monooleate.
Polyethylene glycol (400) monostearate.
Polyethylene glycol (600) monostearate.
Polyethylene glycol (3,000) monostearate.
Polyethylenimine, produced by the polymerization of For use only as an adjuvant employed prior to sheet formation
ethylenimine. in paper-making systems operated at a pH of 4.5 or higher,
and limited to use at a level not to exceed 5% by weight of
finished dry paper or paperboard fibers.
Poly(isobutene)/maleic anhydride adduct, diethanolamine reac- For use only as a surfactant for dispersions of polyacrylamide
tion product. The mole ratio of poly(isobutene)/maleic retention and drainage aids employed prior to the sheet for-
anydride adduct to diethanolamine is 1:1. mation operation in the manufacture of paper and paper-
board.
Polymethacrylic acid, sodium salt, having a viscosity in 30-per- For use only as a coating adjuvant for controlling viscosity
cent-by-weight aqueous solution of 125325 centipoises at when used at a level not to exceed 0.3% by weight of coat-
25 C as determined by LV-series Brookfield viscometer (or ing solids.
equivalent) using a No. 2 spindle at 60 r.p.m.
Polymethacrylic acid, sodium salt, having a viscosity in 40-per- For use only as a coating adjuvant for controlling viscosity
cent-by-weight aqueous solution of 400700 centipoises at when used at a level not to exceed 0.1% by weight of coat-
25 C, as determined by LV-series Brookfield viscometer (or ing solids.
equivalent) using a No. 2 spindle at 30 r.p.m.
206
Poly[(methylimino)(2-hydroxytrimethylene)hydrochloride] pro- For use only as a retention aid employed prior to the sheet-
duced by reaction of 1:1 molar ratio of methylamine and forming operation in such an amount that finished paper and
epichlorohydrin so that a 31-percent aqueous solution at paperboard will contain the additive at a level not in excess
25 C has a Stokes viscosity range of 2.5-4.0 as determined of 1 percent by weight of the dry paper and paperboard.
by ASTM method D154576 (Reapproved; 1981), Standard
Test Method for Viscosity of Transparent Liquids by Bubble
Time Method, which is incorporated by reference. Copies
may be obtained from the American Society for Testing Ma-
terials, 1916 Race St., Philadelphia, PA 19103, or may be
Poly[oxyethylene (dimethyliminio) ethylene (dimethyliminio) For use only to improve dry-strength of paper and paperboard
ethylene dichloride] produced by reacting equimolar quan- and as a retention and drainage aid employed prior to the
tities of N,N,N,N-tetramethylethylene-diamine and sheet-forming operation in the manufacture of paper and pa-
dichlorethyl ether to yield a solution of the solid polymer in perboard and limited to use at a level not to exceed 0.1 per-
distilled water at 25 C with a reduced viscosity of not less cent by weight of the finished dry paper and paperboard fi-
than 0.15 deciliter per gram as determined by ASTM method bers.
D124379, Standard Test Method for -Dilute Solution Vis-
cosity of Vinyl Chloride Polymers, which is incorporated by
reference. Copies may be obtained from the American Soci-
ety for Testing Materials, 1916 Race St., Philadelphia, PA
19103, or may be examined at the National Archives and
Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 2027416030, or go to:
http://www.archives.gov/federallregister/
codeloflfederallregulations/ibrllocations.html.). The fol-
lowing formula is used for determining reduced viscosity:.
Reduced viscosity in terms of deciliters per gram=(tt0)/
(tC),
where:
t=Solution efflux time
to=Water efflux time
C=Concentration of solution in terms of grams per deciliter
Polypropylene glycol (minimum molecular weight 1,000).
Potassium persulfate.
2-Propenoic acid, telomer with sodium 2-methyl-2-[(1-oxo-2- For use only as a deposit control additive employed prior to
propenyl)amino]-1-propane sulfonate and sodium phos- the sheet forming operation in the manufacture of paper and
phinate (CAS Reg. No. 110224992). paperboard and at a level not to exceed 0.15 percent by
weight of the dry paper and paperboard.
Propylene glycol alginate.
Protein hydrolysate from animal hides or soybean protein con-
densed with oleic and/or stearic acid.
Rapeseed oil, sulfated ammonium, potassium, or sodium salt.
Ricebran oil, sulfated ammonium, potassium, or sodium salt.
Rosin and rosin derivatives ......................................................... As provided in 178.3870 of this chapter.
Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1- For use only as a component of polyolefin coatings with
methyl-C9-49-alkyl (CAS Reg. No. 144635085). 177.1520 of this chapter at a level not to exceed 3 percent
by weight. The finished coating will be used only for paper
and paperboard that contact food of types VI-A and VI-B of
table 1 in paragraph (c) of this section, and under conditions
of use C, D, and E, as described in table 2 in paragraph (c)
of this section, with a maximum hot fill temperature of 200 F
(94 C).
Silver chloride-coated titanium dioxide ........................................ For use only as a preservative in polymer latex emulsions at a
level not to exceed 2.2 parts per million (based on silver ion
concentration) in the dry coating.
Sodium carboxymethyl guar gum having a minimum viscosity For use only as a dry-strength and formation-aid agent em-
of 2,700 centipoises at 25 C after 24 hours as determined ployed prior to the sheet-forming operation in the manufac-
by RV-series Brookfield viscometer (or equivalent) using a ture of paper and paperboard and used at a level not to ex-
No. 4 spindle at 20 r.p.m. and using a test sample prepared ceed 1% by weight of finished dry paper or paperboard fi-
by dissolving 8 grams of sodium carboxymethyl guar gum in bers.
392 milliliters of 0.2-percent-by-weight aqueous sodium o-
phenylphenate solution.
Sodium dioctyl sulfosuccinate.
Sodium formaldehyde sulfoxylate ............................................... For use only as polymerization catalyst.
Sodium hypochlorite.
Sodium N-methyl-N-oleyltaurate ................................................. For use only as an adjuvant to control pulp absorbency and
207
176.170 21 CFR Ch. I (4105 Edition)
Sodium nitrite ............................................................................... For use only:

1. At levels not to exceed 0.2% by weight of lubricants or re-
lease agents applied at levels not to exceed 1 lb. per ton of
finished paper or paperboard.
2. As an anticorrosion agent at levels not to exceed 0.2% by
weight of wax emulsions used as internal sizing in the manu-
facture of paper and paperboard prior to the sheet-forming
operation.
Sodium persulfate.
Sodium polyacrylate .................................................................... For use only:
1. As a thickening agent for natural rubber latex coatings, pro-
vided it is used at a level not to exceed 2 percent by weight
of coating solids.
2. As a pigment dispersant in coatings at a level not to exceed
0.25 percent by weight of pigment.
Sodium poly(isopropenylphosphonate) (CAS Reg. No. 118632 For use only in paper mill boilers.
181).
Sodium zinc potassium polyphosphate (CAS Reg. No. 65997 For use only as a pigment dispersant in coatings at a level not
173). to exceed 1 percent by weight of pigment.
Sperm oil, sulfated, ammonium, potassium, or sodium salt.
Stannous oleate.
Stearyl-2-lactylic acid and its calcium salt.
Styrene-butadiene copolymers produced by copolymerizing sty-
rene-butadiene with one or more of the monomers: acryl-
amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, methacrylic acid, and N-methylolacrylamide
(CAS Reg. No. 53504317). The finished copolymers shall
contain not more than 10 weight percent of total polymer
units derived from acrylic acid, fumaric acid, 2-hydroxyethyl
acrylate, itaconic acid, and methacrylic acid, and shall con-
tain not more than 3 weight percent of total polymer units
derived from N-methylolacrylamide, and shall contain not
more than 2 weight percent of polymer units derived from
acrylamide..
Styrene-maleic anhydride copolymer, amidated, ammonium so- For use only as a surface size at a level not to exceed 1 per-
dium salt; having, in a 25 percent by weight aqueous solu- cent by weight of paper or paperboard substrate.
tion at pH 8.8, a minimum viscosity of 600 centipoises at 25
C as determined by Brookfield model LVT viscometer using
a No. 3 spindle at 60 r.p.m. (or equivalent method).
Styrene-maleic anhydride copolymer, sodium salt (minimum For use only:
molecular weight 30,000). 1. As a coating thickening agent at a level not to exceed 1%
by weight of coating solids.
2. As surface size at a level not to exceed 1% by weight of
paper or paperboard substrate.
Styrene-methacrylic acid copolymer, potassium salt (minimum For use only as a coating thickening agent at a level not to ex-
molecular weight 30,000). ceed 1% by weight of coating solids.
Synthetic wax polymer prepared by the catalytic polymerization For use only as a component of petroleum wax and/or syn-
of alpha olefins such that the polymer has a maximum iodine thetic petroleum wax complying with 178.3710 or
number of 18 and a minimum number average molecular 178.3720 of this chapter at levels not to exceed 5 percent
weight of 2,400. by weight of the wax:
1. Under conditions of use F and G described in table 2 of
paragraph (c) of this section for all foods.
2. Under conditions of use E described in table 2 of paragraph
(c) of this section for food Types I, II, IV-B, VI, VII-B and VIII
as described in table 1 of paragraph (c) of this section.
Tallow.
Tallow alcohol.
Tallow alcohol, hydrogenated.
Tallow fatty acid, hydrogenated.
Tallow hydrogenated.
Tallow sulfated, ammonium, potassium, or sodium salt.
Tetraethylenepentamine .............................................................. For use only as a modifier for amino resins.
1,4,4a,9a-Tetrahydro-9, 10-anthracenedione (CAS Reg. No. For use only as a catalyst in the alkaline pulping of
56136142). lignocellulosic materials at levels not to exceed 0.1 percent
by weight of the raw lignocellulosic materials.
N,N,N, N-Tetramethylethylenediamine polymer with bis-(2- For use only as a flocculent, drainage aid or retention aid em-
chloroethyl) ether, first reacted with not more than 5 percent ployed prior to the sheet forming operation in the manufac-
by weight 1-chloro-2,3-epoxypropane and then reacted with ture of paper and paperboard and limited to use at a level
not more than 5 percent by weight poly (acrylic acid) such not to exceed 0.2 percent by weight of the finished dry paper
that a 50 percent by weight aqueous solution of the product and paperboard fibers.
has a nitrogen content of 4.74.9 percent and viscosity of
350700 centipoises at 25 C as determined by LV series
Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or
by other equivalent method).
208
Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfo-suc- For use only as an emulsifier in aqueous dispersions of rosin
cinamate. sizes complying with 178.3870(a)(4) of this chapter and
limited to use prior to the sheet-forming operation in the
manufacture of paper and paperboard at a level not to ex-
ceed 0.02 pct by weight of finished paper and paperboard.
Triethanolamine ........................................................................... For use only to adjust pH during the manufacture of amino res-
ins permitted for use as components of paper and paper-
board.
Triethylene glycol adipic acid monoester produced by reacting For use only as a curl-control agent at a level not to exceed
equimolar quantities of triethylene glycol and adipic acid. 2% by weight of coated or uncoated paper and paperboard.
Triethylenetetramine .................................................................... For use only as a modifier for amino resins.
1,3,5-Triethylhexahydro-1,3,5-triazine (CAS Registry No. 7779 For use only as an antimicrobial agent for coating, binder, pig-
273). ment, filler, sizing, and similar formulations added prior to
the heat drying step in the manufacture of paper and paper-
board and limited to use at a level between 0.05 and 0.15
percent by weight of the formulation.
Undecafluorocyclohexanemethanol ester mixture of dihydrogen For use only as an oil repellent at a level not to exceed 0.087
phosphate, compound with 2,2 iminodiethanol (1:1); hydro- lb (0.046 lb of fluorine) per 1,000 ft2 of treated paper or pa-
gen phosphate, compound with 2,2-iminodiethanol (1:1); and perboard, as determined by analysis for total fluorine in the
P,P-dihydrogen pyrophosphate, compound with 2,2- treated paper or paperboard without correction for any fluo-
iminodiethanol (1:2); where the ester mixture has a fluorine rine which might be present in the untreated paper or paper-
content of 48.3 pct to 53.1 pct as determined on a solids board, when such paper or paperboard is used in contact
basis. with food only of the types identified in paragraph (c) of this
section, table 1, under Types IVA, V, VIIA, VIII, and IX, and
under the conditions of use B through G described in table 2
of paragraph (c) of this section.
Viscose rayon fibers.
Wax, petroleum ........................................................................... Complying with 178.3710 of this chapter.
Xanthan gum, conforming to the identity and specifications pre- For use only at a maximum level of 0.125 percent by weight of
scribed in 172.695 of this chapter, except that the residual finished paper as a suspension aid or stabilizer for aqueous
isopropyl alcohol shall not exceed 6,000 parts per million. pigment slurries employed in the manufacture of paper and
paperboard.
Xylene sulfonic acid-formaldehyde condensate, sodium salt ..... For use only as an adjuvant to control pulp absorbency and
Zeolite Na-A (CAS Reg. No. 68989220) ................................. For use as a pigment extender at levels not to exceed 5.4 per-
cent by weight of the finished paper and paperboard.
Zinc formaldehyde sulfoxylate ..................................................... For use only as polymerization catalyst.
Zinc octoate.
Zirconium oxide ........................................................................... For use only as a component of waterproof coatings where the
zirconium oxide is present at a level not to exceed 1 percent
by weight of the dry paper or paperboard fiber and where
the zirconium oxide is produced by hydrolysis of zirconium
acetate.
(b) Substances identified in para- (1) Substances identified in

graphs (b) (1) and (2) of this section 175.300(b)(3) of this chapter with the
may be used as components of the food- exception of those identified in para-
contact surface of paper and paper- graphs (b)(3) (v), (xv), (xx), (xxvi),
board, provided that the food-contact (xxxi), and (xxxii) of that section and
surface of the paper or paperboard com- paragraph (a) of this section.
plies with the extractives limitations (2) Substances identified in this para-
prescribed in paragraph (c) of this sec- graph (b)(2) follow:
tion.
List of substances Limitations
Acrylamide copolymerized with ethyl acrylate and/or stryene

and/or methacrylic acid, subsequently reacted with formalde-
hyde and butyl alcohol.
Acrylamide copolymerized with ethylene and vinyl chloride in For use only as coatings or components of coatings.
such a manner that the finished copolymers have a minimum
weight average molecular weight of 30,000 and contain not
more than 3.5 weight percent of total polymer units derived
from acrylamide, and in such a manner that the acrylamide
portion may or may not be subsequently partially hydrolyzed.
2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, so- For use only in coatings at a level not to exceed 0.01 mg/in2
dium salt (CAS Reg. No. 35641599).
Acrylic and modified acrylic polymers ......................................... Complying with 177.1010 of this chapter.
209
176.170 21 CFR Ch. I (4105 Edition)
Acrylic copolymers produced by copolymerizing 2 or more of

the acrylate monomers butyl acrylate, ethyl acrylate, ethyl
methacrylate, methyl acrylate, methyl methacrylate, and n-
propyl methacrylate, or produced by copolymerizing one or
more of such acrylate monomers together with one or more
of the monomers acrylic acid, acrylonitrile, butadiene, 2-
ethyl-hexyl acrylate, fumaric acid, glycidyl methacrylate, n-
hexyl-methacrylate, itaconic acid, methacrylic acid, styrene,
vinyl acetate, vinyl chloride, and vinylidene chloride. The fin-
ished copolymers shall contain at least 50 weight percent of
polymer units derived from one or more of the monomers
butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acry-
late, methyl methacrylate, and n-propyl methacrylate; and
shall contain not more than 5 weight percent of total polymer
units derived from acrylic acid, fumaric acid, glycidyl meth-
acrylate, n-hexyl methacrylate, itaconic acid, and methacrylic
acid. The provision limiting the finished acrylic copolymers to
not more than 5 units derived from acrylic acid, fumaric acid,
glycidyl methacrylate, n-hexyl methacrylate, itaconic acid,
and methacrylic acid is not applicable to finished acrylic co-
polymers used as coating adjuvants at a level not exceeding
2 weight percent of total coating solids.
Alkyl mono- and disulfonic acids, sodium salts (produced from For use only:
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings
cent C14-C16).. and limited to use at levels not to exceed 2 percent by
weight of the coating solids.
2. As emulsifiers for vinylidene chloride copolymer or
homopolymer coatings at levels not to exceed a total of
2.6 percent by weight of coating solids. The finished poly-
mer contacts food only of types identified in paragraph (c)
of this section, table 1, under Types I, II, III, IV, V, VIA,
VIB, VII, VIII, and IX and under conditions of use E, F,
and G described in table 2 of paragraph (c) of this section.
2-Bromo-4-hydroxyacetophenone .............................................. For use only as a preservative for coating formulations, bind-
ers, pigment slurries, and sizing solutions at a level not to
exceed 0.006 percent by weight of the coating, solution, slur-
ry or emulsion.
Butylbenzyl phthalate .................................................................. Complying with 178.3740 of this chapter.
Butyl oleate, sulfated, ammonium, potassium, or sodium salt.
Butyraldehyde.
Captan (N-trichloromethylmercapto-4-cyclohexene-1, 2- For use only as a mold- and mildew-proofing agent in coatings
dicarboximide). intended for use in contact with food only of the types identi-
fied in paragraph (c) of this section, table 1, under Type I, II,
VI-B, and VIII.
Castor Oil, polyoxyethylated (42 moles ethylene oxide) ............. For use only as an emulsifier in nitrocellulose coatings for
paper and paperboard intended for use in contact with food
only of the types identified in paragraph (c) of this section,
table 1, under Types IV A, V, VII A, VIII, and IX; and limited
to use at a level not to exceed 8 percent by weight of the
coating solids.
1-(3-Chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride For use only:
(CAS Reg. No. 4080313). 1. As a preservative at a level of 0.3 weight percent in
latexes used as pigment binders in paper and paperboard
intended for use in contact with nonacidic, nonalcoholic
food and under the conditions of use described in para-
graph (c) of this section, table 2, conditions of use E, F,
and G.
2. As a preservative at a level not to exceed 0.07 weight
percent in latexes and 0.05 weight percent in pigment
slurries used as components of coatings for paper and pa-
perboard intended for use in contact with food.
210
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172 For use only:

554) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in
2682204) mixture at a ratio of 3 parts to 1 part, manufac- paper coatings at a level not to exceed 50 parts per mil-
tured from methyl-3-mercaptopropionate (CAS Reg. No. lion (based on isothiazolone active ingredients) in the
2935902). The mixture may contain magnesium nitrate coating formulation.
(CAS Reg. No. 10377603) at a concentration equivalent to 2. As an antimicrobial agent for finished coating formulations
the isothiazolone active ingredients (weight/weight). and for additives used in the manufacture of paper and
paperboard including fillers, binders, pigment slurries, and
sizing solutions at a level not to exceed 25 parts per mil-
lion (based on isothiazolone active ingredients) in the
coating formulations and additives.
Copper 8-quinolinolate ................................................................ For use only as preservative for coating formulations.
Cyclized rubber produced when natural pale crepe rubber dis- For use only in coatings for paper and paperboard intended for
solved in phenol is catalytically cyclized so that the finished use in contact with food only of the types identified in para-
cyclized rubber has a melting point of 145 C to 155 C as graph (c) of this section, table 1, under Types VIII and IX.
determined by ASTM method E2867 (Reapproved 1982),
Standard Test Method for Softening Point by Ring-and-Ball
Apparatus, which is incorporated by reference (Copies may
be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined
at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call 2027416030, or go to: http://www.archives.gov/
ibrllocations.html.), and contains no more than 4000 ppm
of residual-free phenol as determined by a gas liquid
chromatographic procedure titled Determination of Free
Phenol in Cyclized Rubber Resin, which is incorporated by
reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS200), Food and Drug Ad-
ministration, 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call 2027416030, or
go to: http://www.archives.gov/federallregister/
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691657) .. For use only as a preservative at levels not more than 0.05
weight percent and not less than 0.01 weight percent: in
latexes used as pigment binders in coatings; in pigment
slurries used in coatings; and/or in coatings themselves. The
total level of the preservative in the finished coating shall not
exceed 0.04 weight percent of the finished coating solids.
Dibutyl phthalate.
Dibutyl sebacate.
Di(C7,C9-alkyl) adipate ................................................................. Complying with 178.3740 of this chapter.
Dicyclohexyl phthalate.
Diethylene glycol dibenzoate (CAS Reg. No. 120558) ........... For use only as a plasticizer for polyvinyl acetate coatings at a
level not to exceed 5 percent by weight of the coating solids
under conditions described in paragraph (c) of this section,
table 2, conditions of use E, F, and G.
Diethylene glycol ester of the adduct of terpene and maleic an-
hydride.
Dihydroxy dichlorodiphenyl methane .......................................... For use only as preservative for coating formulations.
Dimethylpolysiloxane, 100 centistokes viscosity.
Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane co-
polymer (2:1), 200 to 400 centistokes viscosity.
N,N-Diphenyl-p-phenylenediamine ............................................. For use only as polymerization inhibitor in 2-sulfoethyl meth-
acrylate, sodium salt.
Dipropylene glycol dibenzoate (CAS Reg. No. 27138314) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at
a level not to exceed 5 percent by weight of the coating sol-
ids under conditions described in paragraph (c) of this sec-
tion, table 2, condition of use E.
2. For use only as a plasticizer for polyvinyl acetate coatings at
a level not to exceed 10 percent by weight of the coating
solids under conditions described in paragraph (c) of this
section, table 2, conditions of use F and G.
Disodium N-octadecylsulfosuccinamate ...................................... For use only as an emulsifier in resin latex coatings and limited
to use at a level not to exceed 0.05% by weight of the coat-
ing solids.
EDTA (ethylenediaminetetraacetic acid) and its sodium and/or
calcium salts.
Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- For use only as an insolubilizer for starch-based coatings and
2(1H)pyrimidinone, propoxylated (CAS Reg. No. 118299-90- limited to use at a level not to exceed 5.0 percent by weight
4). of the coating.
211
176.170 21 CFR Ch. I (4105 Edition)
Ethylene-acrylic acid copolymers produced by the copolym-

erization of ethylene and acrylic acid and/or their partial am-
monium salts. The finished copolymer shall contain no more
than 25 weight percent of polymer units derived from acrylic
acid and no more than 0.35 weight percent of residual
monomeric acrylic acid, and have a melt index not to exceed
350 as determined by ASTM method D123882, Standard
Test Method for Flow Rates of Thermoplastics by Extrusion
Plastometer, which is incorporated by reference. Copies
may be obtained from the American Society for Testing Ma-
terials, 1916 Race St., Philadelphia, PA 19103, or may be
Formaldehyde .............................................................................. For use only as preservative for coating formulations.
Glyoxal ......................................................................................... For use only as an insolubilizing agent in starch- and protein-
based coatings that contact nonalcoholic foods, and limited
to use at a level not to exceed 6 percent by weight of the
starch or protein fraction of the coating solids.
Glyceryl monobutyl ricinoleate.
Hydroxymethyl derivatives (mixture of mono and poly) of [N-(1, For use only as a comonomer in polyvinyl acetate latex coat-
1-dimethyl-3-oxobutyl) acrylamide] produced by reacting 1 ings and limited to use at a level not to exceed 1 percent by
mole of the [N-(1,1-dimethyl-3-oxobutyl) acrylamide] with 3 weight of dry polymer solids.
moles of formaldehyde such that the finished product has a
maximum nitrogen content of 6.2 percent and a maximum
hydroxyl content of 15 percent by weight on a dry basis.
Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt.
Maleic anhydride adduct of butadiene-styrene copolymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a-
methylstyrene to 3 vinyltoluene).
Modified kaolin clay (CAS Reg. No. 1344009) is produced For use only as a component of coatings in paper and paper-
by the reaction of sodium silicate (CAS Reg. No. 134409 board products at a level not to exceed 9 percent by weight
8) and kaolinite clay (CAS Reg. No. 1332587) under hy- of the coating intended for use in contact with food of Types
drothermal conditions. The reaction product has a molecular I through IX described in table 1 of paragraph (c) of this sec-
weight between 246 and 365 and consists of 46 to 55 per- tion under conditions of use C through H described in table
cent silicon dioxide (Si02), 28 to 42 percent aluminum oxide 2 of paragraph (c) of this section.
(A1203), and 2 to 7 percent of sodium oxide (Na20). The re-
action product will not consist of more than 70 percent modi-
fied kaolin clay.
Naphthalene sulfonic acid-formaldehyde condensate, sodium
salt.
Oleyl alcohol.
Oxazolidinylethylmethacrylate (CAS Registry No. 46236151) For use only as a binder for pigment coatings as a binder level
copolymer with ethyl acrylate and methyl methacrylate, and not to exceed 4.0 percent by weight of dry paper or paper-
containing not more than 6 percent by weight of board.
oxazolidinylethylmethacrylate. Maximum nitrogen content
shall be 0.5 percent and number average molecular weight
of that portion of the copolymer soluble in tetrahydrofuran
shall be not less than 50,000.
Pentaerythritol tetrastearate.
212
Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use only as modifiers in waxpolymer blend coatings for
product thereof, meeting the following specifications: Soft- corrugated paperboard intended for use in bulk packaging or
ening point 97 C minimum, as determined by ASTM method raw fruits, raw vegetables, iced meat, iced fish, and iced
E2867 (Reapproved 1982), Standard Test Method for Soft- poultry; and limited to use at a level not to exceed 30
ening Point by Ring and Ball Apparatus; aniline point 120 weight-percent of the coating solids.
C minimum, as determined by ASTM method D61182,
Standard Test Methods for Aniline Point and Mixed Aniline
Point of Petroleum Products and Hydrocarbon Solvents,
which are incorporated by reference (Copies may be ob-
tained from the American Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or may be examined at
the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA,
call 2027416030, or go to: http://www.archives.gov/
ibrllocations.html.). Specific gravity 0.960.99 (20 C/20
C). Such petroleum hydrocarbon resins are produced by the
catalytic polymerization of dienes and olefins from low-boiling
distillates of cracked petroleum stocks that contain no mate-
rial boiling over 200 C and that meet the ultraviolet absorb-
ance limits prescribed in 172.880(b) of this chapter when
subjected to the analytical procedure described in
172.886(b) of this chapter, modified as follows: Treat the
product as in the first paragraph under Procedure in
172.250(b)(3) of this chapter. Then proceed with
172.886(b) of this chapter, starting with the paragraph com-
mencing with Promptly complete transfer of the sample
* * *.
Polyester resin formed by the reaction of the methyl ester of
rosin, phthalic anhydride, maleic anhydride and ethylene gly-
col, such that the polyester resin has an acid number of 4 to
11, a drop-softening point of 70 C92 C., and a color of K
or paler.
Polyester resin produced by reacting the acid groups in
montan wax with ethylene glycol.
Polyethylene, oxidized ................................................................. Complying with 177.1620 of this chapter.
Polyethylene reacted with maleic anhydride such that the modi-
fied polyethylene has a saponification number not in excess
of 6 after Soxhlet extraction for 24 hours with anhydrous
ethyl alcohol.
Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt Not to exceed 300 p.p.m. in finished coated paper or paper-
board.
Polyoxypropylene-polyoxyethylene block polymers (minimum
molecular weight 6,800).
Polyvinyl acetate.
Polyvinyl alcohol (minimum viscosity of 4% aqueous solution at
20 C. of 4 centipoises).
Polyvinyl butyral.
Polyvinyl formal.
Polyvinylidene chloride.
Polyvinyl pyrrolidone.
Polyvinyl stearate.
Propylene glycol mono- and diesters of fats and fatty acids.
Siloxanes and silicones; platinum-catalyzed reaction product of For use only as a surface coating. Platinum content not to ex-
vinyl-containing dimethyl polysiloxane (CAS Reg. Nos. ceed 200 parts per million.
68083192 and 68083181) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating
polysiloxane (CAS Reg. No. 63148572) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of
yl hydrogen) polysiloxane (CAS Reg. No. 68037592). this section, table 1, under Types I, II, VI, and VII-B when
Diallyl maleate (CAS Reg No. 999213), dimethyl maleate used under conditions of use E, F, and G described in table
(CAS Reg. No. 624486), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section.
Reg. No. 78273) and vinyl acetate (CAS Reg. No. 108 2. In coatings for paper and paperboard provided the coating
054) may be used as optional polymerization inhibitors. contacts food only of the types identified in paragraph (c) of
this section, table 1, under Types III, IV, V, VII-A, VIII, and
IX when used under conditions of use A through H de-
scribed in table 2 of paragraph (c) of this section.
213
176.170 21 CFR Ch. I (4105 Edition)
Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use
vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives.
68083192 and 68083181), with methyl hydrogen
polysiloxane (CAS Reg. No. 63148572). Dimethyl maleate
(CAS Reg. No. 624486), vinyl acetate (CAS Reg. No.
108054), dibutyl maleate (CAS Reg. No. 105760) and
diallyl maleate (CAS Reg. No. 999213) may be used as
optional polymerization inhibitors. The polymer may also
contain C16-C18 olefins (CAS Reg. No. 68855607) as a
control release agent.
Sodium decylbenzenesulfonate.
Sodium dihexyl sulfosuccinate.
Sodium n-dodecylpolyethoxy (50 moles) sulfate-sodium For use only as an emulsifier in coatings that contact food only
isododecylphenoxypolyethoxy (40 moles) sulfate mixtures. of the types identified in paragraph (c) of this section, table
1, under Types IV-A, V, VII, VIII, and IX; and limited to use
at levels not to exceed 0.75 percent by weight of the coating
solids.
Sodium 2-ethylhexyl sulfate.
Sodium oleoyl isopropanolamide sulfosuccinate.
Sodium pentachlorophenate ........................................................ For use only as preservative for coating formulations.
Sodium o-phenylphenate ............................................................. Do.
Sodium vinyl sulfonate polymerized.
Sodium xylenesulfonate (CAS Reg. No. 1300727) ................. For use only in paper and paperboard coatings at levels not to
exceed 0.01 percent by weight of the finished paper and pa-
perboard.
Styrene copolymers produced by copolymerizing styrene with For use only as a coating or component of coatings and limited
maleic anhydride and its methyl and butyl (sec- or iso-) to use at a level not to exceed 1% by weight of paper or pa-
esters. Such copolymers may contain b-nitrostyrene as a po- perboard substrate.
lymerization chain terminator.
Styrene polymers made by the polymerization of any combina- For use only in contact with foods of Types IV-A, V, and VII in
tion of styrene or alpha methyl styrene with acrylic acid, table 1 of paragraph (c) of this section, under use conditions
methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, E through G in table 2 of paragraph (c), and with foods of
and butyl acrylate. The styrene and alpha methyl styrene, in- Types VIII and IX without use temperature restriction.
dividually, may constitute from 0 to 80 weight percent of the
polymer. The other monomers, individually, may be from 0 to
40 weight percent of the polymer. The polymer number aver-
age molecular weight (Mn) shall be at least 2,000 (as deter-
mined by gel permeation chromatography). The acid number
of the polymer shall be less than 250. The monomer content
shall be less than 0.5 percent.
Styrene-acrylic copolymers (CAS Reg. No. 25950407 pro- For use only as a component of coatings and limited to use at
duced by polymerizing 77 to 83 parts by weight of styrene a level not to exceed 20 percent by weight of the coating
with 13 to 17 parts of methyl methacrylate, 3 to 4 parts of solids.
butyl methacrylate, 0.5 to 2.5 parts of methacrylic acid, and
0.1 to 0.3 part of butyl acrylate such that the finished copoly-
mers have a minimum number average molecular weight
greater than 100,000 and a level of residual styrene mon-
omer in the polymer not to exceed 0.1 percent by weight.
Styrene-butadiene copolymers produced by copolymerizing sty-
rene-butadiene with one or more of the monomer: acryl-
amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, and methacrylic acid. The finished copolymers
shall contain not more than 10 weight percent of total poly-
mer units derived from acrylic acid, fumaric acid, 2-hydroxy-
ethyl acrylate, itaconic acid and methacrylic acid, and shall
contain not more than 2 weight percent of polymer units de-
rived from acrylamide.
Styrene-butadiene copolymers with 2-hydroxyethyl acrylate and
acrylic acid containing not more than 15 weight percent
acrylic acid and no more than 20 weight percent of a com-
bination of 2-hydroxyethyl acrylate and acrylic acid.
Styrene-butadiene-vinylidene chloride copolymers containing For use only as coatings or components of coatings.
not more than 40 weight percent of vinylidene chloride in the
finished copolymers. The finished copolymers may contain
not more than 10 weight percent of total polymer units de-
rived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, and/or methacrylic acid.
214
Styrene-dimethylstyrene-a-methylstyrene copolymers produced For use only in coatings for paper and paperboard intended for
by polymerizing equimolar ratios of the three comonomers use in contact with nonfatty food and limited to use at a level
such that the finished copolymers have a minimum average not to exceed 50% by weight of the coating solids.
molecular weight of 835 as determined by ASTM method
D250382, Standard Test Method for Molecular Weight
(Relative Molecular Mass) of Hydrocarbons by Thermo-
electric Measurement of Vapor Pressure, which is incor-
porated by reference. Copies may be obtained from the
American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the National
Archives and Records Administration (NARA). For informa-
tion on the availability of this material at NARA, call 202
7416030, or go to: http://www.archives.gov/
ibrllocations.html..
Styrene-isobutylene copolymers (weight average molecular For use only in coatings for paper and paperboard intended for
weight not less than 6,300). use in contact under conditions of use D G described in
table 2 of paragraph (c) of this section, with food of Types I,
II, IV-B, VI-B, VII-B, and VIII described in table 1 of para-
graph (c) of this section; and limited to use at a level not to
exceed 40 percent by weight of the coating solids.
Styrene-maleic anhydride copolymers ........................................ For use only as a coating or component of coatings and limited
for use at a level not to exceed 2 percent by weight of paper
or paperboard substrate.
Styrene-methacrylic acid copolymers containing no more than
5 weight percent of polymer units derived from methacrylic
acid.
Styrene-vinylidene chloride copolymers containing not more For use only as coatings or components of coatings.
than 40 weight percent of vinylidene chloride in the finished
copolymers. The finished copolymers may contain not more
than 5 weight percent of total polymer units derived from
acrylic acid, fumaric acid, itaconic acid, and/or methacrylic
acid.
2-Sulfoethyl methacrylate, sodium salt [Chemical Abstracts For use only in copolymer coatings under conditions of use E,
Service No. 1804871]. F, and G described in paragraph (c) of this section, table 2,
and limited to use at a level not to exceed 2.0 percent by
weight of the dry copolymer coating.
a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly (oxy- For use only as a surface-active agent at levels not to exceed
ethylene) hydrogen sulfate, sodium salt mixture with a-[p- 3 percent by weight of vinyl acetate polymer with ethylene
(1,1,3,3-tetramethylbutyl)-phenyl]-omega-hydroxypoly (oxy- and N-(hydroxymethyl) acrylamide intended for use in coat-
ethylene) with both substances having a poly(oxyethylene) ings for paper and paperboard intended for use in contact
content averaging 3 moles. with foods:
1. Of the types identified in paragraph (c) of this section, table
1, under Types I, II, III, IV, VI-B, and VII, and under the con-
ditions of use described in paragraph (c) of this section,
1, under Types V, VIII and IX and under the conditions of
use described in paragraph (c) of this section, table 2, condi-
tions of use C, D, E, F, and G.
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfo-succina- For use only as an emulsifier in resin latex coatings, and lim-
mate. ited to use at a level not to exceed 0.05% by weight of the
coating solids.
Toluenesulfonamide-formaldehyde resins.
215
176.170 21 CFR Ch. I (4105 Edition)
Vinyl acetate copolymers produced by copolymerizing vinyl ac-

etate with one or more of the monomers acrylamide, acrylic
acid, acrylonitrile, bicyclo-[2.2.1]hept-2-ene-6-methylacrylate,
butyl acrylate, crotonic acid, decyl acrylate, diallyl fumarate,
diallyl maleate, diallyl phthalate, dibutyl fumarate, dibutyl
itaconate, dibutylmaleate, di(2-ethylhexyl) maleate, divinyl
benzene, ethyl acrylate, 2-ethyl-hexyl acrylate, fumaric acid,
itaconic acid, maleic acid, methacrylic acid, methyl acrylate,
methyl methacrylate, mono(2-ethylhexyl) maleate, monoethyl
maleate, styrene, vinyl butyrate, vinyl crotonate, vinyl
hexoate, vinylidene chloride, vinyl pelargonate, vinyl propio-
nate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid.
The finished copolymers shall contain at least 50 weight per-
cent of polymer units derived from vinyl acetate and shall
contain no more than 5 weight percent of total polymer units
derived from acrylamide, acrylic acid, crotonic acid, decyl ac-
rylate, dibutyl itaconate, di(2-ethylhexyl) maleate, fumaric
acid, itaconic acid, maleic acid, methacrylic acid, mono(2-
ethylhexyl) maleate, monoethyl maleate, vinyl butyrate, vinyl
hexoate, vinyl pelargonate, vinyl propionate, vinyl stearate,
and vinyl sulfonic acid.
Vinyl acetate polymer with ethylene and N-(hydroxymethyl) ac- For use only in coatings for paper and paperboard intended for
rylamide containing not more than 6 weight percent of total use in contact with foods:
polymer units derived from N-(hydroxymethyl) acrylamide. 1. Of the types identified in paragraph (c) of this section, table
1, under Types I, II, III, IV, VI B, and VII and under the con-
ditions of use described in paragraph (c) of this section,
1, under Types V, VIII, and IX and under the conditions of
use described in paragraph (c) of this section, table 2, condi-
tions of use C, D, E, F, and G.
Vinyl chloride copolymers produced by copolymerizing vinyl
chloride with one or more of the monomers acrylonitrile; fu-
maric acid and its methyl, ethyl, propyl, butyl, amyl, hexyl,
heptyl, or octyl esters; maleic acid and its methyl, ethyl,
propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic an-
hydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl
ester; vinyl acetate-and vinylidene chloride. The finished co-
polymers shall contain at least 50 weight percent of polymer
units derived from vinyl chloride: shall contain no more than
5 weight percent of total polymer units derived from fumaric
and/or maleic acid and/or their methyl, ethyl, propyl, butyl,
amyl, heptyl, or octyl monoesters or from maleic anhydride
or from mono-n-butyl ester of 5-norbornene-2, 3-dicarboxylic
acid (however, in any case the finished copolymers shall
derived from mono-n-butyl ester of 5-norbornene-2,3-
dicarboxylic acid).
Vinyl chloride-vinyl acetate hydroxyl-modified copolymers.
Vinyl chloride-vinyl acetate hydroxyl-modified copolymers re-
acted with trimellitic anhydride.
Vinylidene chloride copolymers produced by copolymerizing vi-
nylidene chloride with one or more of the monomers acryl-
amide acrylic acid, acrylonitrile, butyl acrylate, butyl meth-
acrylate ethyl acrylate, ethyl methacrylate, fumaric acid,
itaconic acid, methacrylic acid, methyl acrylate, methyl meth-
acrylate, octadecyl methacrylate, propyl acrylate, propyl
methacrylate, vinyl chloride and vinyl sulfonic acid. The fin-
ished copolymers shall contain at least 50 weight percent of
polymer units derived from vinylidene chloride; and shall
derived from acrylamide, acrylic acid, fumaric acid, itaconic
acid, methacrylic acid, octadecyl methacrylate, and vinyl sul-
fonic acid.
Colorants:.
Aluminum .............................................................................. For use as a colorant only.
Aluminum hydrate ................................................................ Do.
Aluminum and potassium silicate (mica) ............................. Do.
Aluminum mono-, di-, and tristearate ................................... Do.
Aluminum silicate (China clay) ............................................. Do.
Barium sulfate ...................................................................... Do.
Bentonite .............................................................................. Do.
Bentonite, modified with dimethyldioctadecylammonium ion Do.
Burnt umber .......................................................................... Do.
216
Calcium carbonate ............................................................... Do.

Calcium silicate .................................................................... Do.
Calcium sulfate ..................................................................... Do.
Carbon black (channel process) .......................................... Do.
Cobalt aluminate .................................................................. Do.
Diatomaceous earth ............................................................. Do.
Iron oxides ............................................................................ Do.
Magnesium oxide ................................................................. Do.
Magnesium silicate (talc) ...................................................... Do.
Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, Do.
15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 14714
8).
Raw sienna ........................................................................... Do.
Silica ..................................................................................... Do.
Tartrazine lake (certified FD&C Yellow No. 5 only) ............. Do.
Titanium dioxide ................................................................... Do.
Titanium dioxide-barium sulfate ........................................... Do.
Titanium dioxide-magnesium ............................................... Do.
silicate.
Zinc carbonate ...................................................................... Do.
Zinc oxide ............................................................................. Do.
(c) The food-contact surface of the TABLE 1TYPES OF RAW AND PROCESSED
paper and paperboard in the finished FOODSContinued
form in which it is to contact food, II. Acid, aqueous products; may contain salt or sugar or
both, and including oil-in-water emulsions of low- or high-
when extracted with the solvent or sol- fat content.
vents characterizing the type of food, III. Aqueous, acid or nonacid products containing free oil or
and under conditions of time and tem- fat; may contain salt, and including water-in-oil emulsions
perature characterizing the conditions of low- or high-fat content.
IV. Dairy products and modifications:
of its intended use as determined from
A. Water-in-oil emulsions, high- or low-fat.
tables 1 and 2 of this paragraph, shall B. Oil-in-water emulsions, high- or low-fat.
yield net chloroform-soluble extrac- V. Low-moisture fats and oil.
tives (corrected for wax, petrolatum, VI. Beverages:
mineral oil and zinc extractives as zinc A. Containing up to 8 percent of alcohol.
B. Nonalcoholic.
oleate) not to exceed 0.5 milligram per C. Containing more than 8 percent alcohol.
square inch of food-contact surface as VII. Bakery products other than those included under Types
determined by the methods described VIII or IX of this table:
in paragraph (d) of this section. A. Moist bakery products with surface containing free fat
or oil.
TABLE 1TYPES OF RAW AND PROCESSED B. Moist bakery products with surface containing no free
fat or oil.
FOODS VIII. Dry solids with the surface containing no free fat or oil
I. Nonacid, aqueous products; may contain salt or sugar or (no end test required).
both (pH above 5.0). IX. Dry solids with the surface containing free fat or oil.
TABLE 2TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF
EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER-
BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Food-simulating solvents
8 percent al- 50 percent al-

Types of food Water Heptane 1
Condition of use cohol cohol
(see table 1)
Time and Time and Time and Time and tem-
temperature temperature temperature perature
A. High temperature heat-sterilized (e.g., I, IV-B, VII-B ...... 250 F, 2 hr ..................... ..................... ........................
over 212 F).
III, IV-A, VII-A .... ......do .......... 150 F, 2 hr ..................... ........................
B. Boiling water sterilized .............................. II, VII-B ............... 212 F, 30 ..................... ..................... ........................
min.
III, VII-A .............. ......do .......... 120 F, 30 ..................... ........................
min.
C. Hot filled or pasteurized above 150 F .... II, IV-B, VII-B ..... Fill boiling, ..................... ..................... ........................
cool to
100 F.
217
176.170 21 CFR Ch. I (4105 Edition)
TABLE 2TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF
EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER-
BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGESContinued
Food-simulating solvents
8 percent al- 50 percent al-

Types of food Water Heptane 1
Condition of use cohol cohol
(see table 1)
Time and Time and Time and Time and tem-
temperature temperature temperature perature
III, IV-A, VII-A .... ......do .......... 120 F, 15 ..................... ........................

min.
V, IX ................... ..................... ......do .......... ..................... ........................
D. Hot filled or pasteurized below 150 F ..... II, IV-B, VI-B, ..... ..................... ..................... ..................... ........................
VII-B ................... 150 F, 2 hr ..................... ..................... ........................
III, IV-A, VII-A .... ......do .......... 100 F, 30 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
VI-A .................... ..................... ..................... 150 F, 2 hr ........................
VI-C .................... ..................... ..................... ..................... 150 F, 2 hr.
E. Room temperature filled and stored (no I, II, IV-B, VI-B, 120 F, 24 hr ..................... ..................... ........................
thermal treatment in the container). VII-B.
III, IV-A, VII-A .... ......do .......... 70 F, 30 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
VI-A .................... ..................... ..................... 120 F, 24 hr ........................
VI-C .................... ..................... ..................... ..................... 120 F, 24 hr.
F. Refrigerated storage (no thermal treat- III, IV-A, VII-A .... 70 F, 48 hr 70 F, 30 ..................... ........................
ment in the container). min.
I, II, IV-B, VI-B, ......do .......... ..................... ..................... ........................
VII-B.
VI-A .................... ..................... ..................... 70 F, 48 hr ........................
VI-C .................... ..................... ..................... ..................... 70 F, 48 hr.
G. Frozen storage (no thermal treatment in I, II, IV-B, VII-B .. 70 F, 24 hr ..................... ..................... ........................
the container).
III, VII-A .............. ......do .......... 70 F, 30 ..................... ........................
min.
H. Frozen or refrigerated storage: Ready-
prepared foods intended to be reheated in
container at time of use:
1. Aqueous or oil-in-water emulsion of I, II, IV-B, VII-B .. 212 F, 30 ..................... ..................... ........................
high- or low-fat. min.
2. Aqueous, high- or low-free oil or fat .. III, IV-A, VII-A, IX ......do .......... 120 F, 30 ..................... ........................
min.
1 Heptane extractability results must be divided by a factor of five in arriving at the extractability for a food product having
water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required in the case of wax-polymer blend coatings
for corrugated paperboard containers intended for use in bulk packaging of iced meat, iced fish, and iced poultry.
(d) Analytical methods(1) Selection of freshly demineralized (deionized) dis-

extractability conditions. First ascertain tilled water.
the type of food product (table 1, para- (ii) n-Heptane. Reagent grade, freshly
graph (c) of this section) that is being redistilled before use, using only mate-
packed commercially in the paper or rial boiling at 208 F.
paperboard and the normal conditions (iii) Alcohol. 8 or 50 percent (by vol-
of thermal treatment used in pack- ume), prepared from undenatured 95
aging the type of food involved. Using percent ethyl alcohol diluted with
table 2, paragraph (c) of this section, demineralized (deionized) distilled
select the food-simulating solvent or water.
solvents and the time-temperature ex- (iv) Chloroform. Reagent grade, fresh-
aggerations of the paper or paperboard ly redistilled before use, or a grade
use conditions. Having selected the ap- having an established consistently low
propriate food-simulating solvent or blank.
solvents and the time-temperature ex- (3) Selection of test method. Paper or
aggeration over normal use, follow the paperboard ready for use in packaging
applicable extraction procedure. shall be tested by use of the extraction
(2) Reagents(i) Water. All water used cell described in Official Methods of
in extraction procedures should be Analysis of the Association of Official
218
Analytical Chemists, 13th Ed. (1980), (e) Forced draft oven.

sections 21.01021.015, under Exposing For each extraction, the following ad-
Flexible Barrier Materials for Extrac- ditional apparatus is necessary:
tion, which is incorporated by ref- (f) One No. 2 paper clip.
erence (Copies may be obtained from (g) One 800-milliliter beaker with
the Association of Official Analytical watch-glass cover.
Chemists International, 481 North (h) One 250-milliliter beaker.
Frederick Ave., suite 500, Gaithersburg, (i) Five 212-inch-square aluminum
MD 208772504, or may be examined at screens (standard aluminum window
the National Archives and Records Ad- screening is acceptable).
ministration (NARA). For information (j) One wire capable of supporting
on the availability of this material at sample stack.
NARA, call 2027416030, or go to: http:// (ii) Procedure. (a) For each extrac-
www.archives.gov/federallregister/ tion, accurately cut eight 212-inch-
codeloflfederallregulations/ square samples from the formed paper
ibrllocations.html.); also described in or paperboard product to be tested.
ASTM method F3476 (Reapproved (b) Carefully stack the eight 212-inch-
1980), Standard Test Method for Liq- square samples and the five 212-inch-
uid Extraction of Flexible Barrier Ma- square aluminum screens in sandwich
terials, which is incorporated by ref- form such that the food-contact side of
erence (copies may be obtained from each sample is always next to an alu-
the American Society for Testing Ma- minum screen, as follows: Screen, sam-
terials, 1916 Race St., Philadelphia, PA ple, sample, screen, sample, sample,
19103, or may be examined at the Na- screen, etc. Clip the sandwich together
tional Archives and Records Adminis- carefully with a No. 2 paper clip, leav-
tration (NARA). For information on ing just enough space at the top to slip
the availability of this material at a wire through.
NARA, call 2027416030, or go to: http:// (c) Place an 800-milliliter beaker con-
www.archives.gov/federallregister/ taining 100-milliliters of the appro-
codeloflfederallregulations/ priate food-simulating solvent into the
ibrllocations.html.), except that formed constant temperature bath, cover with
paper and paperboard products may be a watch glass and condition at the de-
tested in the container by adapting the sired temperature.
in-container methods described in (d) After conditioning, carefully
175.300(e) of this chapter. Formed lower the sample sandwich with tongs
paper and paperboard products such as into the beaker.
containers and lids, that cannot be (e) At the end of the extraction pe-
tested satisfactorily by any of the riod, using the tongs, carefully lift out
above methods may be tested in spe- the sample sandwich and hang it over
cially designed extraction equipment, the beaker with the wire.
usually consisting of clamping devices (f) After draining, pour the food-sim-
that fit the closure or container so ulating solvent solution into a tared
that the food-contact surface can be 250-milliliter beaker. Rinse the 800-mil-
tested, or, if flat samples can be cut liliter beaker three times, using a total
from the formed paper or paperboard of not more than 50 milliliters of the
products without destroying the integ- required solvent.
rity of the food-contact surface, they (g) Determine total nonvolatile ex-
may be tested by adapting the fol- tractives in accordance with paragraph
lowing sandwich method: (d)(5) of this section.
(i) Apparatus. (a) Thermostated (1.0 (4) Selection of samples. Quadruplicate
F) water bath, variable between 70 F samples should be tested, using for
and 120 F water bath cover capable of each replicate sample the number of
holding at least one 800-milliliter beak- cups, containers, or preformed or con-
er partially submersed in bath. verted products nearest to an area of
(b) Analytical balance sensitive to 0.1 100 square inches.
milligram with an approximate capac- (5) Determination of amount of extrac-
ity of 100 grams. tives(i) Total residues. At the end of
(c) Tongs. the exposure period, remove the test
(d) Hood and hot-plate facilities. container or test cell from the oven
219
176.170 21 CFR Ch. I (4105 Edition)
and combine the solvent for each rep- (or equivalent) in a Pyrex (or equiva-
licate in a clean Pyrex (or equivalent) lent) funnel, collecting the filtrate in a
flask or beaker being sure to rinse the clean, tared evaporating dish (platinum
test container or cell with a small or Pyrex). Repeat the chloroform ex-
quantity of clean solvent. Evaporate traction, washing the filter paper with
the food-simulating solvents to about this second portion of chloroform. Add
100 milliliters in the flask or beaker, this filtrate to the original filtrate and
and transfer to a clean, tared evaporate the total down to a few mil-
evaporating dish (platinum or Pyrex), liliters on a low-temperature hotplate.
washing the flask three times with The last few milliliters should be evap-
small portions of solvent used in the orated in an oven maintained at ap-
extraction procedure, and evaporate to proximately 221 F. Cool the
a few milliliters on a nonsparking, low- evaporating dish in a desiccator for 30
temperature hotplate. The last few minutes and weigh to the nearest 0.1
milliliters should be evaporated in an
milligram to get the chloroform-solu-
oven maintained at a temperature of
ble extractives residue (). This is sub-
approximately 221 F. Cool the
stituted for e in the equations in para-
evaporating dish in a desiccator for 30
minutes and weigh the residue to the graph (d)(5)(i) (a) and (b) of this sec-
nearest 0.1 milligram, (e). Calculate the tion. If the chloroform-soluble extrac-
extractives in milligrams per square tives in milligrams per square inch
inch of the container or sheeted paper still exceeds the limitation prescribed
or paperboard surface. in paragraph (c) of this section, proceed
(a) Water and 8- and 50-percent alcohol. to paragraph (d)(5)(iii) of this section
Milligrams extractives per square (method for determining corrected
inch=(e)/(s). chloroform-soluble extractives res-
(b) Heptane. Milligrams extractives idue).
per square inch=(e)/(s)(F) (iii) Corrected chloroform-soluble ex-
where: tractives residue(a) Correction for zinc
e=Milligrams extractives per sample tested. extractives. Ash the residue in the
s=Surface area tested, in square inches. evaporating dish by heating gently
F=Five, the ratio of the amount of extrac- over a Meker-type burner to destroy
tives removed by heptane under exagger- organic matter and hold at red heat for
ated time-temperature test conditions about 1 minute. Cool in the air for 3
compared to the amount extracted by a fat minutes, and place the evaporating
or oil under exaggerated conditions of
thermal sterilization and use.
dish in the desiccator for 30 minutes
e=Chloroform-soluble extractives residue. and weigh to the nearest 0.1 milligram.
ee=Corrected chloroform-soluble extractives Analyze this ash for zinc by standard
residue. Association of Official Agricultural
e or ee is substituted for e in the above equa- Chemists methods or equivalent. Cal-
tions when necessary. culate the zinc in the ash as zinc ole-
If when calculated by the equations in ate, and subtract from the weight of
paragraph (d)(5)(i) (a) and (b) of this chloroform-soluble extractives residue
section, the extractives in milligrams () to obtain the zinc-corrected chloro-
per square inch exceeds the limitations form-soluble extractives residue (e).
prescribed in paragraph (c) of this sec- This e is substituted for e in the equa-
tion, proceed to paragraph (d)(5)(ii) of tions in paragraph (d)(5)(i) (a) and (b) of
this section (method for determining this section.
the amount of chloroform-soluble ex- (b) Correction for wax, petrolatum, and
tractives residues). mineral oil(1) Apparatus. Standard 10
(ii) Chloroform-soluble extractives res- millimeter inside diameter 60 centi-
idue. Add 50 milliliters of chloroform meter chromatographic column (or
(freshly distilled reagent grade or a standard 50-milliliter buret with an in-
grade having an established consist- side diameter of 1011 millimeters)
ently low blank) to the dried and with a stopcock of glass,
weighed residue, (e), in the evaporating perfluorocarbon resin, or equivalent
dish obtained in paragraph (d)(5)(i) of material. The column (or buret) may
this section. Warm carefully, and filter be optionally equipped with an integral
through Whatman No. 41 filter paper coarse, fritted glass disc and the top of
220
the column (or buret) may be option- filtrate with an additional 1015 milli-
ally fitted with a 100-millimeter sol- liters of heptane and add to the col-
vent reservoir. umn. Wash (elute) the column with
(2) Preparation of column. Place a more heptane collecting about 100 mil-
snug pledget of fine glass wool in the liliters of total eluate including that
bottom of the column (or buret) if the already collected in the evaporating
column (or buret) is not equipped with dish. Evaporate the combined eluate in
integral coarse, fritted glass disc. Over- the evaporating dish to dryness on a
lay the glass wool pledget (or fritted steam bath. Dry the residue for 15 min-
glass disc) with a 1520 millimeter deep utes in an oven maintained at a tem-
layer of fine sand. Measure in a grad- perature of approximately 221 F. Cool
uated cylinder 15 milliliters of the evaporating dish in a desiccator for
chromatographic grade aluminum 30 minutes and weigh the residue to the
oxide (80200 mesh) that has been tight- nearest 0.1 milligram. Subtract the
ly settled by tapping the cylinder. weight of the residue from the weight
Transfer the aluminum oxide to the of chloroform-soluble extractives res-
chromatographic tube, tapping the idue () to obtain the wax-, petrolatum-
tube during and after the transfer so as , and mineral oil-corrected chloroform-
to tightly settle the aluminum oxide. soluble extractives residue (e). This e
Overlay the layer of aluminum oxide is substituted for e in the equations in
with a 1.01.5 centimeter deep layer of paragraph (d)(5)(i) (a) and (b) of this
anhydrous sodium sulfate and on top of section.
this place an 810 millimeter thick plug (ii) For chloroform residues weighing
of fine glass wool. Next carefully add more than 0.5 gram. Redissolve the
about 25 milliliters of heptane to the dried and weighed chloroform-soluble
column with stopcock open, and allow extract residue as described in para-
the heptane to pass through the col- graph (d)(5)(iii)(b)(3)(i) of this section
umn until the top level of the liquid using proportionately larger quantities
just passes into the top glass wool plug of heptane. Transfer the heptane solu-
in the column, and close stopcock. tion to an appropriate-sized volumetric
(3) Chromatographing of sample ex- flask (i.e., a 250-milliliter flask for
tract(i) For chloroform residues weigh- about 2.5 grams of residue) and adjust
ing 0.5 gram or less. To the dried and to volume with additional heptane. Pi-
weighed chloroform-soluble extract pette out an aliquot (about 50 milli-
residue in the evaporating dish, ob- liters) calculated to contain 0.10.5
tained in paragraph (d)(5)(ii) of this gram of the chloroform-soluble extract
section, add 20 milliliters of heptane residue and analyze
and stir. If necessary, heat carefully to chromatographically as described in
dissolve the residue. Additional paragraph (d)(5)(iii)(b)(3)(i) of this sec-
heptane not to exceed a total volume of tion. In this case the weight of the
50 milliliters may be used if necessary dried residue from the heptane eluate
to complete dissolving. Cool to room must be multiplied by the dilution fac-
temperature. (If solution becomes tor to obtain the weight of wax, petro-
cloudy, use the procedure in paragraph latum, and mineral oil residue to be
(d)(5)(iii)(b)(3)(ii) of this section to ob- subtracted from the weight of chloro-
tain an aliquot of heptane solution cal- form-soluble extractives residue () to
culated to contain 0.10.5 gram of chlo- obtain the wax-, petrolatum-, and min-
roform-soluble extract residue.) Trans- eral oil-corrected chloroform-soluble
fer the clear liquid solution to the col- extractives residue (e). This e is sub-
umn (or buret). Rinse the dish with 10 stituted for e in the equations in para-
millimeters of additional heptane and graph (d)(5)(i) (a) and (b) of this sec-
add to column. Allow the liquid to pass tion. (Note: In the case of chloroform-
through the column into a clean, tared soluble extracts which contain high
evaporating dish (platinum or Pyrex) melting waxes (melting point greater
at a dropwise rate of about 2 milliliters than 170 F), it may be necessary to di-
per minute until the liquid surface lute the heptane solution further so
reaches the top glass wool plug; then that a 50-milliliter aliquot will contain
close the stopcock temporarily. Rinse only 0.10.2 gram of the chloroform-
the Pyrex flask which contained the soluble extract residue.)
221
176.180 21 CFR Ch. I (4105 Edition)
(e) Acrylonitrile copolymers identi- holding dry food of the type identified
fied in this section shall comply with in 176.170(c), table 1, under Type VIII,
the provisions of 180.22 of this chap- subject to the provisions of this sec-
ter, except where the copolymers are tion.
restricted to use in contact with food (a) The substances are used in
only of the type identified in paragraph amounts not to exceed that required to
(c), table 1 under Category VIII. accomplish their intended physical or
[42 FR 14554, Mar. 15, 1977] technical effect, and are so used as to
EDITORIAL NOTE: For FEDERAL REGISTER ci- accomplish no effect in food other than
tations affecting 176.170, see the List of CFR that ordinarily accomplished by pack-
Sections Affected, which appears in the aging.
Finding Aids section of the printed volume (b) The substances permitted to be
and on GPO Access.
used include the following:
176.180 Components of paper and pa- (1) Substances that by 176.170 and
perboard in contact with dry food. other applicable regulations in parts
The substances listed in this section 170 through 189 of this chapter may be
may be safely used as components of safely used as components of the
the uncoated or coated food-contact uncoated or coated food-contact sur-
surface of paper and paperboard in- face of paper and paperboard, subject
tended for use in producing, manufac- to the provisions of such regulation.
turing, packing, processing, preparing, (2) Substances identified in the fol-
treating, packaging, transporting, or lowing list:
Acrylamide polymer with sodium 2-acrylamido-2- For use at a level not to exceed 0.015 weight percent of dry
methylpropane-sulfonate (CAS Reg. No. 38193601). fiber.
(2-Alkenyl) succinic anhydrides in which the alkenyl groups are
derived from olefins which contain not less than 78 percent
C30 and higher groups (CAS Reg. No. 70983550)..
4-[2-[2-(2-Alkoxy(C12-C15) ethoxy) ethoxy]ethyl]disodium sulfo- For use as a polymerization emulsifier and latex emulsion sta-
succinate. bilizer at levels not to exceed 5 percent by weight of total
emulsion solids.
Alkyl mono- and disulfonic acids, sodium salts (produced from
n-alkanes in the range of C10-C18 with not less than 50 per-
cent C14-C16)..
Aluminum and calcium salts of FD & C dyes on a substrate of Colorant.
alumina.
Ammonium nitrate..
Amylose..
Barium metaborate ...................................................................... For use as preservative in coatings and sizings.
1,2-Benzisothiazolin-3-one (CAS Registry No. 2634335) ....... For use only as a preservative in paper coating compositions
and limited to use at a level not to exceed 0.02 mg/in2
(0.0031 mg/cm2) of finished paper and paperboard.
N,N-Bis(hydroxyethyl)lauramide.
Bis(trichloromethyl) sulfone C.A. Registry No. 3064708 ......... For use only as a preservative in coatings.
Borax ........................................................................................... For use as preservative in coatings.
Boric acid ..................................................................................... Do.
sec-Butyl alcohol..
Butyl benzyl phthalate..
Candelilla wax..
Carbon tetrachloride..
Castor oil, polyoxyethylated (42 moles ethylene oxide)..
Cationic soy protein hydrolyzed (hydrolyzed soy protein isolate For use only as a coating adhesive, pigment structuring agent,
modified by treatment with 3-chloro-2-hydroxypropyl- and fiber retention aid.
trimethylammonium chloride).
Cationic soy protein (soy protein isolate modified by treatment For use only as a coating adhesive, pigment structuring agent,
with 3-chloro-2-hydroxypropyltrimethyl-ammonium chloride). and fiber retention aid.
Chloral hydrate ............................................................................ Polymerization reaction-control agent.
N-Cyclohexyl-p-toluene sulfonamide..
2,5-Di-tert-butyl hydroquinone.
Diethanolamine..
Diethylene glycol dibenzoate (CAS Reg. No. 120558) ........... For use only as a plasticizer in polymeric substances.
Diethylene glycol monobutyl ether..
Diethylene glycol monoethyl ether..
Diethylenetriamine..
222

CFR 176 170

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176.170 21 CFR Ch.

films or grease-resistant papers con- Provided, That the components of the

Acetyl peroxide ............................................................................ For use only as polymerization catalyst.

List of Substances Limitations

List of Substances Limitations

List of Substances Limitations

Cumene hydroperoxide ............................................................... Do.

List of Substances Limitations

List of Substances Limitations

1. For contact only with nonalcoholic food having a pH above 5

List of Substances Limitations

List of Substances Limitations

List of Substances Limitations

List of Substances Limitations

List of Substances Limitations

Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062 For use only:

List of Substances Limitations

List of Substances Limitations

Sodium nitrite ............................................................................... For use only:

List of Substances Limitations

(b) Substances identified in para- (1) Substances identified in

Acrylamide copolymerized with ethyl acrylate and/or stryene

List of substances Limitations

Acrylic copolymers produced by copolymerizing 2 or more of

List of substances Limitations

5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172 For use only:

List of substances Limitations

Ethylene-acrylic acid copolymers produced by the copolym-

List of substances Limitations

List of substances Limitations

List of substances Limitations

List of substances Limitations

Vinyl acetate copolymers produced by copolymerizing vinyl ac-

List of substances Limitations

Calcium carbonate ............................................................... Do.

8 percent al- 50 percent al-

8 percent al- 50 percent al-

III, IV-A, VII-A .... ......do .......... 120 F, 15 ..................... ........................

(d) Analytical methods(1) Selection of freshly demineralized (deionized) dis-

Analytical Chemists, 13th Ed. (1980), (e) Forced draft oven.

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